DR. NARENDRA GUPTA vs. UNION OF INDIA

Reportable IN THE SUPREME COURT OF INDIA CIVIL ORIGINAL JURISDICTION Writ Petition (Civil) No 131 of 2013 Dr Narendra Gupta ... Petitioner(s) Versus Union of India & Ors ... Respondent(s) J U D G M E N T Dr Dhananjaya Y Chandrachud, CJI 1. A public interest litigation has been instituted by Dr Narendra Gupta in 2013 highlighting the fact that in the States of Bihar, Chhattisgarh and Rajasthan, in particular, “unnecessary hysterectomies” were carried out under the Rashtriya Swasthya Bima Yojana as well as other government schemes related to healthcare. The petition also highlights the involvement of private hospitals in Signature Not Verified Digitally signed by Sanjay Kumar Date: 2023.04.10 15:55:09 IST Reason: performing such hysterectomies. The Union Ministry of Health and Family 2 1 Welfare is the first respondent, while the States of Bihar, Rajasthan and Chhattisgarh are impleaded as the second, third and fourth respondents respectively. Based on his field work, the petitioner has brought to our notice the fact that women, who should not have been subjected to hysterectomies and to whom alternative treatment could have been extended, were subjected to hysterectomies, seriously endangering their health in the process. The petitioner also submitted that most women who were subjected to hysterectomies of this kind belonged to the Scheduled Castes, Scheduled Tribes, or Other Backward Communities. 2. On 13 December 2022, this Court directed the Secretary, MoHFW to examine the grievance which was raised in the petition and to file a response after collating relevant information. 3. Before we advert to the status report which has been filed by the Union of India, it must be recorded, at the outset, that from the counter affidavits filed by the States of Rajasthan, Bihar and Chhattisgarh, it emerges that there is a considerable degree of substance in the facts which have been highlighted in the petition. For instance, the affidavit filed by the State of Bihar indicates that steps were taken by the district authorities in Kishanganj, Madhubani, Samastipur and Saran to enquire into complaints regarding unnecessary hysterectomies. Finding that many of the allegations in regard to the performance of unnecessary hysterectomies were true, 1 “MoHFW” 3 the State has taken consequential action. It issued a circular inter alia directing that empanelled hospitals must obtain permission from the concerned insurance provider before conducting hysterectomies on women aged forty or below. This Court has been apprised of the fact that several hospitals have been blacklisted and de-empanelled from the Rashtriya Swasthya Bima Yojana pursuant to the investigation conducted in the state. In certain cases, First Information Reports have been filed. 4. The State of Rajasthan has placed on the record the steps which were taken by the District Collector, Dausa for constituting committees to enquire into the alleged incidents. The State of Rajasthan framed the Rajasthan Government Clinical Establishments (Registration and Regulation) Rules 2013. The State of Chhattisgarh constituted a High Powered Committee which found that the hysterectomies in the state could not be termed as “wholly unneeded.” 5. The right to health is an intrinsic element of the right to life under Article 21 of the Constitution. Life, to be enjoyed in all its diverse elements, must be based on robust conditions of health. There has been a serious violation of the fundamental rights of the women who underwent unnecessary hysterectomies. 6. In 2022, MoHFW issued guidelines titled “Guidelines to Prevent Unnecessary 4 2 Hysterectomies,” which have been forwarded to all the States and Union Territories for compliance. The Guidelines were formulated after a series of consultations with different stake holders. The Guidelines indicate that while in developed countries hysterectomies are typically conducted amongst pre- menopausal women above the age of forty-five years, in India, community based studies have consistently found rising hysterectomy rates among young women, ranging from twenty-eight to thirty-six years of age. Field based studies have indicated that unnecessary hysterectomies are performed in cases where medical or non-invasive treatment would have been sufficient. The evidence indicates a higher risk among poor, less educated women, particularly in the rural areas. 7. Paragraphs 5.1.3 to 5.1.5 of the affidavit filed by the Secretary, MoHFW are set out below: “5.1.3. Data from National Family Health Survey-4 (2015-16) estimates hysterectomy prevalence to be 3.6% amongst women aged 36-39 years, 9.2% amongst women aged 40-49 years and the median age for hysterectomy is 37 years. 5.1.4 Notably, two-thirds of the procedures were conducted in private facilities. 5.1.5 A working paper from the National Health Authority on early trends from AB-PMJAY indicates that 2% of the claims submitted by women were for hysterectomy. Notably, six states – Chhattisgarh, Uttar Pradesh, Jharkhand, Gujarat, Maharashtra and Karnataka – generated three quarters of all hysterectomy claims.” 2 “Guidelines” 5 8. In 2019, a national consultation on unnecessary hysterectomies identified three important challenges: a. The need for appropriate clinical and population level guidelines; b. Availability of appropriate information on and treatment of gynaecological morbidity at the primary level; and c. The critical need to monitor and regulate the appropriate use of hysterectomies, particularly for treatment of benign gynaecological conditions and amongst younger women. 9. Chapter 3 of the Guidelines provides guidance on prevention of unnecessary hysterectomies. It refers to the role of programme managers and also refers to the role of different levels of public health facilities. The Guidelines note that reporting of hysterectomies, cases conducted for women less than 40 years of age and the cause of the hysterectomy have to be incorporated in the existing screening checklist. To achieve this, the Guidelines propose the setting up of Hysterectomy Monitoring Committees at District, State and National levels. Chapter 3 also deals with District, State and National Hysterectomy Monitoring Committees in the following terms: “ District Hysterectomy Monitoring Committees A District Hysterectomy Monitoring Committee must be set up in each 6 district to enable effective monitoring. The committee must be set up under the chairpersonship of District CMO. NCD Nodal, District RCH Nodal Officers/ Maternal Health Nodal Officers, other key government personnel at the district level, representatives from FOGSI (both public and private sector), representatives from development partners etc. The monitoring committee is expected to:  Issue necessary orders to both public and private sectors to submit a line list of all women who underwent hysterectomy every month. The line list must include information on parameters such as: • Age • Parity • Occupation • Indication of hysterectomy • Previous medical/surgical history • Hysterectomy route: • Abdominal • Vaginal • Laparoscopic • Any other surgery done along with hysterectomy: • Past treatment history: • HPE:  Every quarter the district committee must audit cases with following indications and issue necessary instructions if required: • Hysterectomy with/ without BSO in women <35 yrs. of age 7 • Hysterectomy with BSO in women< 40 yrs. of age • All cases where no indication for doing the procedure is mentioned in the records • All cases where no records of treatment prior to hysterectomy (in papers or in history) are available • Discrepancy between mentioned indication and HPE report o Any severe morbidity/mortality due to hysterectomy • Annexure 3 provides detailed guidelines on how to conduct audits of hysterectomies • Arrange necessary trainings and sensitization sessions for both public and private sector professionals. State Hysterectomy Monitoring Committees A State Hysterectomy Monitoring Committee must be set up in each State to enable effective monitoring. The committee must be set up under the chairpersonship of State Principle Secretary. State level DPH (Director Pubtic Health) will be the nodal Officer & NCD State program officer, RCH/FW/MH programme officers will be the other key government personnel at the state level, representatives from FOGSI (both public and private sector), representatives from development partners etc. The monitoring committee is expected to meet once in every six months and review district level data to ensure that unnecessary hysterectomies can be avoided. The State Hysterectomy Monitoring Committees must also arrange necessary trainings and sensitization sessions for both public and private sector professionals and district officials. National Hysterectomy Monitoring Committees A National Hysterectomy Monitoring Committee must be set up to enable effective monitoring and ensure necessary policy decisions at the National level. The monitoring committee would comprise of officials from NCD, ICMR, MH Officers under the chairpersonship of Additional Commisssioner & Mission Director, NHM and is expected to meet once in every six months and review State level data to ensure that unnecessary hysterectomies can be avoided. The national committees must also 8 arrange necessary trainings and sensitization sessions for both public and private sector professionals and district officials. Most importantly national committees must review the landscape and take necessary policy decisions as required.” 10. The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana which provides an annual health cover of Rs. 5 lakhs per family has been extended to cover twelve crore families across the nation. The scheme covers the treatment of 1949 procedures, including hysterectomies under 27 different specialties. As of 16 March 2023, 45,434 hospital admissions were authorized under this scheme for hysterectomy related treatments. Two Standard Treatment Guidelines have been developed for fourteen procedures relating to hysterectomies. The Union government has set out the details of procedures and State/UT-wise details of authorized hospital admissions for the purpose of hysterectomies under the Scheme. 11. Besides setting out the provisions of the Guidelines, the status report filed by the Union government indicates the steps which were taken by the States of Chhattisgarh and Bihar while dealing with the performance of unnecessary hysterectomies. 12. The Union government has proposed an action plan in its status report, which is set out below: “E. PROPOSED ACTION PLAN 9 10. Setting Up of Grievance Portal - It is pertinent to mention here that the Rasthriya Swasthya Bima Yojana (RSBY) has been subsumed in PMJAY with the launch of Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) on 23.09.2018. The PMJAY website hosts a grievance portal for its beneficiaries. An additional grievance portal would also be maintained by National Health Authority especially designed for PMJAY beneficiaries of hysterectomies. The proposed portal will be activated for hysterectomy beneficiaries within a period of three months. Any grievance received on the portal will be monitored by the National Hysterectomy Monitoring Committee. 11. Formation of Committees – The Ministry will endeavour to form a National Hysterectomy Monitoring Committee, as proposed under the Guidelines within 4 to 6 weeks. Simultaneously the states will also be continuously advised to expedite formation of the state and district level committees so that the implementation of the National Guidelines can be properly monitored and supervised.” 13. The Guidelines which have been adopted by MoHFW to prevent unnecessary hysterectomies must be adopted by all the States and Union Territories. MoHFW shall engage with all the States and Union Territories to ensure that the Guidelines are adopted expeditiously. We direct that: a. All States and Union Territories shall adopt the Guidelines within three months and report compliance to MoHFW; b. All the States and Union Territories shall implement the Guidelines without delay and report compliance to MoHFW; and c. All the States and Union Territories shall ensure that all public and private hospitals within their territories are made aware of the existence and 10 importance of the Guidelines. The Guidelines, for convenience of reference, are annexed to this judgment as Annexure A to facilitate compliance. 14. Ms. Kawalpreet Kaur, counsel appearing on behalf of the petitioner, has urged two submissions which seek to supplement the Guidelines. Firstly, it has been submitted that under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana, where a hysterectomy is performed on a woman below the age of forty years, the requirement of the procedure has to be certified by at least two doctors. The suggestion is that this requirement should be extended to other cases as well, irrespective of the age of the woman undergoing a hysterectomy. 15. Responding to the above submission of Ms Kawalpreet Kaur, Ms Aishwarya Bhati, Additional Solicitor General, submits that once the full data on hysterectomies is duly captured on the portal of MoHFW and the National, State, and District Level Committees are constituted, a considered decision will be taken by the Union of India on this aspect. The Additional Solicitor General submitted that while certain States already have such a procedure in place, the network of government hospitals may not be adequate enough to implement such a regulation across India even if it were made. Moreover, the ASG urged that there is a real danger that this may result in the denial of treatment to women who are genuinely in the need of it. It has been submitted that since the situation is evolving, the Union of 11 India would take a considered view once adequate data is available. 16. We accept the submission. 17. The Guidelines mandate that the National Committee should review the landscape and take necessary policy decisions, as required, once in every six months. 18. The second suggestion which has been urged on behalf of the petitioner is that the state should take steps for blacklisting hospitals where hysterectomies were carried out without medical necessity and without obtaining the informed consent of the patient. In this context, it was urged that as a first line of treatment, other non-invasive methods should be adopted and, in any event, the woman who is undergoing the hysterectomy should be properly informed about the reason and likely consequences of the hysterectomy, bearing on the health of the patient. 19. We are in agreement with the submission that all the States and Union Territories must take stringent action for blacklisting hospitals once it is detected that any unnecessary hysterectomy was carried out or that the procedure was taken recourse to without the informed consent of the patient. We direct that necessary action be taken in accordance with law. 20. Since steps have been taken by the Union government in framing the Guidelines in 2022 and the States of Chhattisgarh, Bihar and Rajasthan have indicated to the Court of the steps which were taken to detect unnecessary hysterectomies and to 12 deal with them, we see no further reason to keep the petition alive. 21. The Union government shall take all necessary steps in accordance with the Guidelines to effectuate the public interest which is sought to be achieved. 22. We appreciate the assistance which has been rendered to the Court by Ms Kawalpreet Kaur, counsel appearing on behalf of the petitioner and Ms Aishwarya Bhati, Additional Solicitor General. 23. The petition is disposed of in terms of the above directions. 24. Pending applications, if any, stand disposed of. ..…..…....…........……………….…........CJI. [Dr Dhananjaya Y Chandrachud] …..…..…....…........……………….…........J. [J B Pardiwala] New Delhi; April 05, 2023 -S- 542/694   -     -0/.
0 24 ANNEXURE-A TO PREVENT GUIDELINES UNNECESSARY HYSTERECTOMIES OF FAMILY ^WETFARE MINISTRY HEALTH & MATERNAT HEALTH DIYISION 543/694   -     -0/.
0 25 Index Page No Topic Sr No ') Introduction I 4 ) for Hysterectomy Common Indications Programmatic Guidelines o Overview o MonitoringMechanisms Generation o Awareness 7 3 Management by ANMS/ ^CHOs & Clinical Protocols for t6 4 Medical Officers 17 5 Overview of Treatment ^Modalities Annexures Providers 1) Roles of Different Basic Facts about ^{Hysterectomies} 2) on Audits for ^{Hysterectomies} 3) Guidance .,) 6 for ^AUB Detailed Treament Modalities DUB 4 1 544/694   -     -0/.
0 26 INTRODUCTION Hysterectomy, the surgical removal of the uterus, is the most common non- gynaecological amongst age group. The obstetric surgery women in reproductive most common medical indications for hysterectomy include fibroids, abnormal uterine bleedin& uterine prolapse, chronic pelvic pain and premalignant and malignant tumours of uterus and cervix. Hysterectomy with Oophorectomy (Removal further lead of ovaries] leads to surgical menopause which may to menopausal symptoms such as hot flashes, vaginal dryness, urinary incontinence, sexual dysfunction and long term consequences like osteoporosis and CVS diseases. Oophorectomy the symptoms of menopause. worsens early developed countries, hysterectomy typically pre- In is conducted amongst menopausal women above age 45 years. ln lndia, there is increasing concern about patterns of hysterectomy at a population level. Community-based studies have consistently found rising hysterectomy rates amongst young women, rangingfrom 28 36 years. Further, evidence less ro indicates a higher risk amongst poor, educated women in ruraI areas. Field-based reports have also suggested that there are unnecessary hysterectomies performed in cases where medical or non- invasive treatment would have been sufficient. There are also reports of potential coercion for financial benefit under health insurance schemes and concerns pertaining to lack of information provided to women on side effects. Data from the National Family Health Survey-4 estimates hysterectomy [2015-16J prevalence to be 3.6%o amongst women 30-39 years and 9.2y0 amongst women 40- 49 years. The median age at hysterectomy was 37 years (amongst womenwho were 40-49 at the time of surveyJ. Two-thirds of procedures were conductedin Excessive private facilities. menstrual bleeding or pain was self-reported as the leading indication hysterectomy, for followed by fibroids and uterine disorder. Prevalence varied greatly across states, with prevalence from 20-23 percent of women in ages 40-49 in Andhra Pradesh and Telangana-close to high-income countries-yet at a considerably low median age. Data also show variation across states indicating uneven availability of treatment for women for common gynaecological disorders at primary health care levell. NFHS 5 paper A working from the National Health Authority on early trends from Ayushman Bharat Pradhan Mantri Arogya Yojana (AB-PM-IAYJ Jan indicates that 2%o of claims submitted for women were for hysterectomy. Six states (Chhattisgarh, Uttar Pradesh, .lharkhand, Gujarat, Maharashtra and Karnataka) 1 Desai S, Shukla A, Nambiar D, Ved R. Patterns of hysterectomy in lndia: a national and statelevel analysis of the Fourth appears in National Family Health Survey (20'15-2016) [published correction (1'l],:e'122. BJOG. 2020 Octi'127 Shuka, A A]1. BJOG. 2019;126 Suppt4(Suppt [corrected to Shukla, Suppl 4):72-80. doiil 0. 1 1 1 1 I 1 47 1 -0528. 1 5858 2 545/694   -     -0/.
0 27 also ^generated three- quarters number of ^{claims under} PM-fAY and had overall high for ^hysterectomy claims. ^The median ^age of ^claims submitted of all hysterectomy package ^{covered was} hysterectomy under PM-JAY was 44 ^{years. The} most common have suggesting up ^to half ^of claimants ^may with salpingo-oopherectomy, that ovaries, ^which in ^turn may ^{render women vulnerable to} undergone removal ofthe a range ofside effects. 2079 on ^{unnecessary hysterectomy} identified ^three A national consultation in challenges for women's ^health: important * population-level guidelines on The need for appropriate clinical and hysterectomy * on and treatment ofgynecological Availability ofappropriate information morbidity at the primary care level * and regulate the appropriate use ofhysterectomy, A critical need to monitor for treatment of benign gynecological conditions ^{and amongst} particularly younger women. purpose is The of this document to: Provide guidance to public health programme managers on ^{measures to} 1. focus ^on address unnecessary hysterectomy at the facility level, including at ^the community level. monitoring and awareness generation activities guidelines common conditions that ^constitute key 2. Provide clinical on pathways indications for hysterectomy. To focus on ^providing treatment for lower abnormal uterine bleeding/dysfunctional uterine bleeding discharge, abnormal looking cervix and abdominal pain, vaginal guidelines, uterovaginal prolapse, drawing from existing government evidence reviews and expert consultation. 3 546/694   -     -0/.
0 28 COMMON INDICATIONS FOR HYSTERECTOMY Evidence reviews and expert consultations have highlighted the following common indications for Hysterectomy in our country: . Abnormal Uterine Bleeding/ Dysfunctional Uterine Bleeding . Vaginal Discharge o Lower abdominal pain/Pelvic Inflammatory Disease [PID) . Abnormal looking cervix . UterocervicovaginalProlapse ABNORMAL UTERINE BLEEDING (AUB) Abnormal uterine bleeding is a broad term that describes irregularities in the menstrual cycle involving frequency, regularity, duration, and volume of flow outside of pregnancy. Up to one-third of women will experience abnormal uterine bleeding in their life, with irregularities most commonly occurring at menarche and perimenopause. A a normal menstrual cycle has frequency of 24 to 38 days, lasts 7 to 9 days, with 5 to 80 ml of blood loss. Variations in any of these 4 parameters constitute abnormal uterine bleeding. Older terms such as oligomenorrhea, menorrhagia, and dysfunctional uterine bleeding should be discarded in favour ofusing simple terms to describe the nature of the abnormal uterine bleeding. Revisions to the terminology were first published in 2007, followed updates from the International Federation and by of Obstetrics in 2011 and 2018. The FIGO systems first define the abnormal Gynaecology IFIGOJ uterine bleeding then give an acronym for common aetiologies. These descriptions apply to chronic, nongestational AUB. In 2018, the committee added intermenstrual bleeding and defined irregular bleeding as outside the 75th percentile. Abnormal uterine bleeding can also be divided into acute versus chronic. Acute AUB is excessive bleeding which requires immediate intervention to prevent further bloodloss. Acute AUB can occur on its own or superimposed on AUB, chronic which refers to irregularities in menstrual bleeding for most of the previous 6 months. rABLs Potentiat cau$es of abnormal uterine bleeding according to the PALM-COEIN classitications pd't : structural lobgy rnsss{.rrable i ttrougfr Unagklo or l*stopstlrology Polyp Ad6nomlroslS Lalqn).ome nldlgnancy & hyp€rga8ia pathy Coa8ult l : Elt€odlng €latsd to stritctural u abnorffialili6s Ovutatory ctlsofclers Encrorr€trial dysfunctlon latrogsnlc llot oth€rwise classaf i6d 4 547/694   -     -0/.
0 29 UTEROCEVICAL AND UTEROVAGINAL PROLAPSE and when pelvic ^floor muscles and ^ligaments stretch weaken and Uterine prolapse occurs slips ^{down into} provide enough support for the ^uterus. As ^a result, the uterus no longer in ^{women of any} age. ^Butit of the vagina. Uterine ^prolapse can ^occur or protrudes out have ^had one ^or more ^{vaginal deliveries. Mild} often affects postmenopausal women ^who prolapse require treatment, ^But if ^uterine starts uterine prolapse usually doesn't then occurs the routine activities ^and disrupts ^the normal ^life benefit interfering with of prolapse is ^age and ^fertility related. from the treatment. The ^management uterovaginal The ^{conservative surgical operations are gaining} Not everyone requires hysterectomy. popularity. Several sling operations ^are available now. more VAGINAL DISCHARGE presenting symptoms of ^women to ^a Vaginal discharge is one of the most common pathological physiological. may affect women of any ^age doctor's office. It may be or It group. Even when is pathological, it may be treated by means ofantibiotics prescribed it the woman and often times also to ^her partner. ^However persistent vaginal ^discharge to which ^is not treated despite treatment requires further investigation. Vaginal discharge with ^{the routine} activities, ^affect the or inappropriately treated can start interfering work and also ^give rise to more severe forms ^of pelvic infections, often woman's ability to leading women to opt for hysterectomy specially in the underdeveloped sectors ofthe not easy to approach. It ^is very important ^both for ^the country where referral centers are patient care provider to understand that hysterectomy is not ^a treatment and the health of vaginal discharge. LOWER ABDOMINAL PAIN: to Lower abdominal pain or pelvic pain are common complaints compelling women provider. pain may be acute or chronic. Most commonly it ^is visit the health care This pain, the causes of which may be difficult to ^{diagnose, hence} making the chronic pelvic treatment difficult. Owing to this often both the health care ^provider and the ^patient pelvic pain resort to hysterectomy as the final answer. The most common cause ofchronic Disease (PIDJ. Treatment PID is mostly outpatient in women is Pelvic Inflammatory of non-surgical prolonged course of antibiotics. Only a few ^patients and requiring a grade blood counts may presenting with acute symptoms like high fever and increased admission. Conservative surgery may be needed only in cases with ^pelvic abscess. require 5 548/694   -     -0/.
0 30 Unhealthy Cervix: ofCervix Pre-cancerous Lesions / lead ^to an ^unhealthy looking pre-cancerous cervical ^{lesions may} often Chronic cervicitis or cervical may be ^treated by ^{medical management} or cervix with chronic ^discharge, which evaluation to excisional techniques. Hence, an ^{unhealthy Iooking cervix requires} ablation or all ^cases. precancerous Iesions ^but does ^{not require hysterectomy in} rule out cancerous or 6 549/694   -     -0/.
0 31 PROGRAMMATIC GUIDANCE 7 550/694   -     -0/.
0 32 PROGRAMMATIC GUIDANCE The purpose of this section is to provide programme managers guidance on prevention of unnecessary hysterectomy by raising awareness among health providers regarding alternative methods oftreatment available for gynaecologicaI diseases aswell as in the community regarding indications hysterectomy of and disadvantages of unnecessary hysterectomy. While the burden of hysterectomies varies across states, variation in national patterns suggests a lack of uniform services available treat to gynaecological morbidity. Hitherto the health system has focused largely on obstetric and family planning services, aligned with the aim to reduce maternal mortality and address unmet need for family planning. Accordingly, financial and human resources at all levels, including outreach services, were primarily related to pregnancy, delivery, post -partum care and family planning. As of now, other than Community Health Centres, District Hospitals and Medical colleges, there are limited services in public health facilities to treat appropriately or refer women with gynaecological complaints. Women often undergo surgery for gynaecological conditions may possibly respond to medical or non- surgical interventions. The lack of services for such conditions have many reasons including high obstetric case-loads, a shortage of Medical officers and specialists, and on account of limited knowledge among service providers on updated methods of non- surgical methods for treatment. Programme officers are expected to ensure training of all cadres of workers including the ones at the frontline, supply of medicines and other logistics, enable the delivery of high quality services at primary and secondary care levels including provision of NCDs at HWC'S and create the mechanism for community awareness and facilitate the conduct of medical and social audits. The role of programme managers in reducing unnecessary hysterectomy is to: 1. Communicate the range of interventions to be provided at each level ofthe health system gynecological for as well as obstetric ailments and thereby eliminate unnecessary hysterectomy 2. Build capacity of secondary and primary level service providers fMedical Officers, Staff Nurses, CHOs, LHV/ANMon women,s health needs for gynecological services 3. Ensure that the PHC team at Health and Wellness Centers is able to make appropriate referrals and ensure that medicines prescribed at the higher levels is dispensed at HWC-SHC (lfavailablel and that continuum ofcare is maintained 4. Enable improved public understanding of the various gynecological problems a woman may develop, the plethora of medical management and non- surgical interventions available to treat them, the consequences of unnecessary hysterectomy and guide women on care-seeking for gynecological morbidity through building community awareness 8 551/694   -     -0/.
0 33 tike ^PM]AY financed health insurance Ensure awareness ^{regarding publicly} 5. undergo are ^eligible for the ^{scheme and} are ^{required to} amongst those who out ^{of pocket expenditure} and in order to ^reduce indicated hysterectomy provide financial ^protection. thus 9 552/694   -     -0/.
0 34 Facilities of Different Levels ^of Public Health Role TheroleofHWCs/SC/PHC/CHC/SDH/DH/MCaccordingtoconditionsleading have ^been listed ^{for the common} conditions: with ^{Hysterectomy,} to/associated sized ^uterus) with/without Bleeding with normal 1a. Abnormal Uterine IMenorrhagia dysmenorrhoea with ^enlarged uterus) lb. Abnormal Uterine ^Bleeding [Menorrhagia Metrorrhagia, Oligomenorrhoea, Amenorrhoea 1c. Abnormal Uterine ^Bleeding: (obese, ^{hypertensive, diabetic or} a bleeding in high ^{risk group} followed by irregular years cancer), AUB ⁱⁿ women ^above 40 ofage family or cervical history ofendometrial OR Persistent dysmenorrhoea Pelvic pain ^t Backache 2. AbnormaI VaginaI ^Discharge t prolapse 3. Utero-cervical 4. Lower abdominal Pain 5. Abnormal or unhealthy cervix hysterectomy ^at age less hysterectomy ^{care in} women who ^have undergone 6. Post - than 45 ^years. performed to ^{treat uncontrolled} PPH 7. Emergency hysterectomy each ^{level of the} health provides details on what ^is exoected at Annexure 1 common gynaecological symptoms, the system (HWCs/SC/PHC/CHC/SDH/DH/MCl for level, ofservices including ^{essential drugs} role ofthe service provider at each and details be provided at ^{the level} ofthe ^facility. and diagnostics to Community Awareness hysterectomy are ^available to ^the community. It is essential that facts about platforms such as Village Health, Sanitation and ^Nutrition Committees, Women's Existing at ^{PHC, CHC} and Self-Help Groups, Mahila Arogya ^Samities, and ^Rogi Kalyan Samities used information through ^frontline workers district hospitals could be to disseminate and MPW- F. Discussions should focus ^on removing myths such as ASHA and hygiene practices, misconceptions in the community and ^{raising awareness} on ^menstrual practices, gynaecological ^problems in ^women, prevention of PID's and STD, safe sex other malignancies and ^plenty oftreatment modalities ^available for risk factors for genital tract as as of hysterectomy in ^these conditions' ^Emphasis should ^be treatment well the role laid on the fact that hysterectomy is ^not the first ^choice oftreatment for ^most conditions' guidance programs to ^build This section of the document provides on developing hysterectomy. It ^focuses on ^providing basic facts community awareness on unnecessary on hysterectomv and components ofa communication ^strategv. l0 553/694   -     -0/.
0 35 Basic Facts on Hysterectomy the community and available to is essential that ^facts about hysterectomy are It provides clear, simple ^information in ^particular. Annexure 2 community health workers awareness' can be used ^to raise ^community on hysterectomy that Communication strategies can ^help build ^awareness in ^the community: Existing agencies that in ^each village and ^Nutrition Committee 1. Village Health, Sanitation each ^Anganwadi Women's Self Help Groups linked to 2. 3. Mahila Aarogya Samitis group in ^each Anganwadi 4. Mother's H Standing Committee on ealth in every gram panchayat 5. School Management Committees in every school 6. Kalyan Samities ^at PHC, CHC ^and district ^hospitals 7. Rogi Other community based organizations 8. Ward and ^gram sabhas 9. Health Societies 10. District prevention: Principles for community awareness on ^hysterectomy IEC ^materials building should ^be done ⁱⁿ local ^{language and} 1. Community awareness must be developed accordinglY language. Print ^{material, videos} and apps ^can All FAQs must be translated into ^local 2. free to ^use once ^downloaded and usable ^{offline. They} can be used. Apps must be provide on menstrual hygiene and hysterectomy related ^information information for both service providers and women promoted as ^a low ^cost non-surgical alternative to LNG IUS must be 3. ever feasible hysterectomy where hysterectomy Testimonies of women who experienced ^{adverse effects} after 4. adverse ^effects following hysterectomy Testimonies of caregivers who witnessed ofdoctors, Counsellors, Teachers etc 5. Professional Testimonies fournalists, You can make a difference by: community Removing myths and misconceptions in the Avoiding unnecessary Hysterectomies Campaigning for preventing unnecessary Hysterectomy existing ^NCD platform. The training for all levels may be conducted through lt 554/694   -     -0/.
0 36 hysterectomy strate$I2 Designing a Communication research ^can Findings from formative to develop and ^design be used customized and standardized ^messages for behaviour change. Review; Literature Formative Research 1. Key Messages - policy ^makers for Policy Makers sensitization ^{and advocacy} with 2. Target Population a mechanisms ^{to prevent} creating policies and institutional (bureaucrats, executives ^etc.J unnecessary hysterectomy providers - sensitization ^and advocacy with ^service Service etc.) ^for uptake of provides (such as doctors, RMPs, Nursing Homes desired practices of change - Community . Women: the women and her immediate family members are b c. to follow ^{desired practices} made aware ol and are encouraged of change RMPs, Influencers: ^{(relatives, peer,} fellow ^{villagers, doctors,} ' etc.J ^are made nursing homes, Iabour contractors, employers and are encouraged to promote the dissemination ^and aware ol uptake of desired practices of change. 3. Platforms Seminars (for policy makers, ^{executives, service} Workshops, providers etc.) Community level Events and Institutions as ^{VHSNDs, AWCs,} [such School Management SHGs, Gram Sabha, Health Centres, Schools/ PTAS etc.) Committees/ Kilns, Sugar Farms, Railways Labour Chowks, Brick Factory/ Bus Stations etc. Stations, 4. Medium a. Docudrama [Video-based Use community based video production or employ professionals to produce small docudramas. Videos produced can be screened at the various platforms (above) or sent through WhatsApp, or on broadcasted local TV Approach) phones, PICO projectors, smart and TAB can be used for screening videos Use a of ^push and pull b. IVR (Community Radio) combination call system only '1lndicative t2 555/694   -     -0/.
0 37 on ^a Toll ^Free Allow the user to ^call Number and listen ^to Pre-recorded her ^queries. FAQs or record at railways stations, C Wall paintings labour chowk, PHC, etc. Wall Painting/ ^FliP FlYers charts/ Dangles, (Conventional etc. Approach) level ^of Specific posters for ^each Facilities. an ^effective Whats App can become medium of dissemination Social Media, d. TV, Radio, WhatsApp (ASHA, ANM, of various ^{government departments} Frontline workers 5. Change Agents AWwetc.J Gram institutions Farmers groups, Community [Women's Sroups, etc.) Panchayat, School Management ^Committees Employers Doctors, RMPs, Labour ^Contractors, Labour +* RMPs, labour contractors and employer can be Influencers like the ^role of if sensitized and encouraged ^{to undertake} highly effective change agent. of monitoring and ^evaluation of ^the Identi$r suitable indicators 6. Monitoring and Evaluation cases : ^{No&#x27; of} Hysterectomy communication interventions like a ^system of conducted < 40 ^years and ^{cause of} hysterectomy.Design women's health continuous tracking of ^practices and ^{trends around} and unnecessary hysterectomy. l3 556/694   -     -0/.
0 38 & Monitoring Evaluation < cases conducted 40 years like; ^No. of Hysterectomy Reporting of hysterectomy incorporated the ^existing NCD screening cause of hysterectomy need ^to be in and at both ^State Hysterectomies must ^be regularly monitored checklist. Data ^pertaining to needs ^to be ^monitored and Data from ^{both public} and ^{private sector} and District levels. professionals and ^private sector ^as government institutions, medicaI from both public come make this ^monitoring a ^success. well as other stakeholders ^must together to Monitoring Committees District Hysterectomy must ^{be set} up in ^each district A District Hysterectomy Monitoring Committee The must ^be set ^up under ^the chairpersonship to enable effective monitoring. committee District ^RCH Nodal Officers Maternal ^{Health Nodal Officers,} ofDistrict CMO. NCD Nodal, / FOGSI ^(both key government personnel at the ^district level, ^{representatives} from other development partners etc. ^The public and private sectorJ, representatives from to: monitoring committee is expected a orders to both ^public and ^private sectors ^{to submit} line ^list ofall . Issue necessary line must ^include women who underwent hysterectomy every month. The list parameters as: information on such Age o Parity o o Occupation lndication of hysterectomy o Previousmedical/surgicalhistory o Hysterectomy route: o . Abdominal Vaginal ' . Laparoscopic Any other surgery done along with hysterectomy: o Past treatment history: o HPE: o . Every quarter the district committee must audit ^cases with ^following indications and issue necessary instructions if required: <35 with/ without BS0 ⁱⁿ women yrs. ^of age o Hysterectomy BSO in women ^&lt; 40 ^yrs. of ^age o Hysterectomy with the ^procedure is ^mentioned in ^the All cases where no indication for doing o records prior to hysterectomy papers All cases where no records of treatment o [in or in history) are available HPE report Discrepancy between mentioned indication and o Any severe morbidity/mortality due to hysterectomy o 14 557/694   -     -0/.
0 39 Annexure 3 provides detailed guidance on how to conduct audits of hysterectomies public Arrange necessary trainings and sensitization sessions for both and private sector professionals. state Hysterectomy Monitoring committees A State Hysterectomy Monitoring Committee must be set up in each State to enable effective monitoring. The committee must be set up under the chairpersonship of State Principle Secretary. State level DPH (Director Pubtic Health) will be the nodal NCD Officer & State program officer, RCH/FW/MH programme officers will be the other key government personnel at the state level, representatives from FOGSI (both pubtic and private sector), representatives from development partners etc. The monitoring committee is expected to meet once in every six months and review district level data to ensure unnecessary hysterectomies that can be avoided. The State Hysterectomy Monitoring Committees must also arrange necessary trainings and sensitization sessions for both public and private sector professionals and district officials. National Hysterectomy Monitoring Committees National Hysterectomy A Monitoring Committee must be set up to enable effective monitoring and ensure necessary policy decisions at National level. The the monitoring committee would comprise of officials from NCD, ICMR, MH Officers under the chairpersonship of Additional Commisssioner & Mission Director, NHM and is expected to meet once in every six months and review State level data to ensure that unnecessary hysterectomies can be avoided. The national committees must also arrange necessary trainings and sensitization sessions both public private sector for and professionals and district officials. Most importantly national committees must review the landscape and take necessary policy decisions as required. l5 558/694   -     -0/.
0 40 CLINICAL PROTOCOLS This section focuses on clinical ^protocols for management at the ^{level of} ANMs and ^at the level of CHOs/ Medical Officers 16 559/694   -     -0/.
0 41 FOR MODALITIES AVAILABLE MANAGEMENT VARIOUS HYSTERCTOMY available for ^common with various ^rreatrnent modalities This section deals Dysfunctional Uterine namely Abnormal Uterine Bleeding/ indications of hysterectomy Disease Prolapse, Vaginal Discharge, Pelvic ^Inflammatory Bleeding uterocervicovaginal (PIDJ & Abnormal Cervix OF MANAGEMENT AVAILABLE FORAUB/ DUB MODALITIES on ^{clinical stability,} suspected ^aetiologr of Choice of treatment for AUB/DUB depends and medical problems. The ^two main bleeding desire for future fertility underllng are: objectives of managing acute AUB heavy bleeding 1.J To control the current episodes of loss cycles 2.1 To reduce menstrual blood in subsequent Medical therapy is considered the ^preferred initial treatment. Medical management: anti- Medical treatment options for DUB include tranexamic acid, ^nonsteroidal progestogen, inflammatory drugs combined oral contraception pill, danazol INSAIDsJ, and gonadotropin-releasing hormone analogues ^(GnRH-a). Another medical method ^for (Mirena@J. the treatment of DUB is the levonorgestrel-releasing intrauterine system It was developed as a contraceptive method but has been ^proven quite originally , it DUB, so the device acquired approval for that ^indication effective in the treatment of too. to medical rreatment, physicians should offer Surgical methods: In cases ofAUB resistant patients, choose to women surgical treatment. In such one could between endometrial patient's age, ^physical ablation techniques and hysterectomy, taking into consideration condition, and will. DUB Detailed treatment modalities for AUB/ are annexed (Annexure 4), 17 560/694   -     -0/.
0 42 MoDALtTIEsoFMANAGEMENTAVAIIABLEFoRUTERoVAGINAIPRoIIIPSE specially in younger prolapse is also ^not a ^{direct indication ofhysterectomy} Uterovaginal new group ^hysterectomy is the ^{better option. There are} age group. In elderly ^age which ^have forni ^of various sling operations modalities of conservative ^{surgeries in the} been recommended in order ^to avoid hysterectomy' are ^- Various sling operations . Shirodkar sling . Purandarecervicopexy . Khanna sling Soonawalla sling . . sling loshi Virkud sling . Others . surgeries: There are also different types of reconstructive (uterosacral ligament suspension and Fixation or suspension using ^your own tissues "native repair," this ^is used ^to treat ^uterine sacrospinous fixationJ called tissue -Also performed vagina. The prolapsed ^part is or vaginal vault prolapse. It is through the a in the pelvis. ^A procedure to prevent attached with stitches to a ligament or ^to muscle urinary incontinence may be done at tle ^same time. prolapse (front) wall ^of the ^vagina and Colporrhaphy to treat of the anterior -Used is ^performed prolapse of the posterior (back) wall of the vagina. This type of surgery once ^again through the vagina. Stitches are used to strengthen the vagina so ^that it supports the bladder or tlle rectum. prolapse be done Sacrocolpopexy to treat vaginal vault and enterocele. lt ^can -Used with an abdominal incision or with laparoscopy. Surgical mesh ^is attached to the front walls of the vagina and then.to the sacrum bone). This lifu the ^vagina and back [tail back into ^place. Sacrohysteropexy prolapse when a woman does not want to treat uterine -Used a Surgical mesh is attached to the cervix and then to the sacrum, ^lifting hysterectomy. place. the uterus back into placed mesh-Used to treat all types of ^prolapse. Can ^be used Surgery using vaginally tissues are strong enough for native tissue repair. Vaginally in women whose own not placed mesh has a significant risk of severe complications, including mesh erosion, pain, infection, and bladder or bowel injury. This type of surgery should be reserved justi$ for women in whom the benefis may the risks. 18 561/694   -     -0/.
0 43 MODALITIES OF MANAGEMENT AVAILABTE FOR PRE.CANCEROUS LESIONS OF CERVIX UNHEALTHY CERVIX: / Cervical screening is recommended in: . All symptomatic women giving history of chronic leucorrhoea, postcoital bleeding or unhealthy appearance ofcervix should be investigated with VIA or Pap smear. Age o 30-65 years o All HIV infected as soon as women the infection is diagnosed o Women having symptoms and visible growth, plaque that bleeds on touch: Cervical biopsy from the growth/lesion r Women having infective discharge: Antibiotics. Follow up after 7 days. Medical Trearment for cervical infection o Cefixime, 400 mg orally single dose plus Azithromycin, 19 orally single dose 1 hourbefore food . Treatment of partner o Gening HIVVDRL test o Follow-up 7 after days o When there is no infection conduct the following tests Evaluation 1) Visual Inspection (Visual Inspection after acetic Lugol,s iodine acid [VIA), or tvrr) o Visual inspection of cervix after painting it with 4-5%o acetic acid for 1 minute orand turn yellow after application of iodine. If VIA is negative assure the woman. Repeat VIA every 5 years o If VIA test is positive (shows dense white, opaque acetowhite lesions in - transformation zone) colposcopy and directed biopsy should be done. 2) Pap smear Liquid-Based (LBC) Cytolory (ifavailable) / o Send the smears to pathologist requesting for results as per Bethesda system (2001). Review the result ofsmear. o With ASCUS cytologr do colposcopy orVIA, followed by biopsy if suspicious areas are identified. Alternatively, it can be triaged with repeat cytolory at one year. Women o with cytolory report LSIL should preferably undergo colposcopy and directed biopsy. o Women with cervical cytolos/ report of ASC-H or HSIL be should advised to undergo colposcopy and directed biopsy. women with cytolory report of atypical glandular cells should be evaluated with colposcopy and directed biopsy along with endocervical and endometrial sampling. 19 562/694   -     -0/.
0 44 3) HPV testing: for high-risk HPV type ifavailable and affordable. Negative HPV test with other tests is more assuring and can help prolong the repeat screen interval to 5 years. Treatment of CIN on Histopathology of biopsy specimen r Women having low-grade (ASCUS LSIL) Pap smear and CIN 1 on histologr / should be 1 yearly advised to continue with follow up with VIA/Pap smear under supervision. o Women with high grade (ASC-H, HSIL) smear abnormalties and CIN histologu t should be advised cytolory after 6 montls or immediate treatment depending on their compliance and desire. . If high grade smear abnormality persists 12 for months and no lesion is seen on colposcopy a diagnostic performed. excision should be o With CIN 2/3, if colposcopy is adequate, both excision and ablation are adequate modalities oftreatmenL Excision is preferred to ablation. o Excision is recommended if recurrent CIN, endocervical involvement or colposcopy is inadequate. r Immediate hysterectomy for CIN2/3 is unacceptable. o Hysterectomy can be an alternative to repeat excision/ cone is feasible. biopsy o Ifbiopsy shows invasive cancer at any time, staging and management according to the stage ofdisease should be done in the appropriate center. MODALITIES OF TREATMENT AVAILABLE FOR VAGINAL DISCHARGE Vulvo vaginal infections are among the most patients frequent disorders for which seek care from gynecologists. By understanding the pathophysiolory of these diseases, and having an effective approach to their diagnosis, physicians can institute appropriate antimicrobial therapy to treat t}rese conditions and reduce long-term sequelae. Common Causes: o Vaginitis can be ofthree types: Trichomonal, candidial vaginitis. Bacterial vaginosis. Mixed. o Cervical infection due to gonorrhea and Chlamydia infection. . Genital herpes. Normal vaginal discharge: Normal vaginal secretions are floccular in consistency, white in color, and usually located in the dependent poftion ofthe vagina (posterior fornix). Treatment: . Depends on accurate diagnosis based on symptoms and examination findings o Once diagnosed can be managed with antimicrobials o Ifclinical examination is suggestive ofenlarged uterus, adnexal mass or tenderness in pelvis then patient be should referred for ultrasonography. 20 563/694   -     -0/.
0 45 infection, diabetes mellitus, ^{immunosuppressive conditions, steroid} o Exclude HIV to ^higher center' cases of ^recurrent infection ^and refer therapy in (D/TPID): FOR ^LOWER ABDOMINAL ^PAIN OF AVAILABLE MODALITIES TREAIMENT pain lower ^abdominal group women often ^present with ^chronic Reproductive age be painful menstruation which ^can baci<ache, vaginal discharge and associated with tow is abdominal pain One ^{of the} common causes of lower treated by medical treatmenL the (PlD). is ^caused by ^{microorganisms colonizing} Pelvic initammatory disease lt causes ^{of pain} the ^endometrium and ^fallopian tubes. ^other endocervix and ascending to uterus' pelvic ^adhesions, adnexal ^mass or ^fibroid may be endometriosis, adenomyosis, Diagnosis examination. o Should be based on history and symptoms and ^signs, diagnosis of PID is based on a triad ^of o Traditionally, the the ^presence pain, cervical ^motion and adnexal tenderness, and including pelvic of fever. pelvis be in cases with ^palpable masses in the or . Ultrasonography may advised incases with acute tenderness. Treatment of Lower Abdominal ^Pain: is to the cause. . Treatment directed of infection. o Treatment progestogens-MPA/Dienogest ,GnRHa) o Medical treatment for endometriosis, (oCP/ lesions, etc. o Laparoscopic adhesiolysis, fulguration ofendometriotic pain. not have any gmecological cause for ^pelvic o Sometimes the woman may such as gastrointestinal infections or infestations or . Other medical conditions can ^be with ^appropriate abdominal TB could be responsible which treated antimicrobial agents. & lmprove general health o Correct Anemia, under nutrition 21 564/694   -     -0/.
0 46 Annexure 1 at ^{various levels} of ^care Table: Responsiveness sized with or without with - 1a. AUB Point of Care Human Resource/ ^Service Medicines Diagnostics (Essential List of Level Provider ASHA/MAS: Uterine ofwomen ^{using checklist} for Abnormal o Annual screening Commun ity +Sub centre Bleeding (AUB). D3 Oral iron and calcium with supplementation' [Daily . elemental iron ^and daily requirement of requirement of Oral lron-60mg Calcium-500mg. ASHA/ANM: up of women ^{taking treatment} for ^Abnormal o Ensure follow d home visits. Uterine Bleed Hwc/ PHC/Non FRU CHC CHO Hb (initial and when needed during follow up) lf women fit into 1a category after at PHC assessment and are advised medical PHC management by M0 (MBBS), then dispense following drugs in subsequent cycles: Tab. Tranexamic o / Refer all women with Heavy Menstrual Bleeding to PHC for initial assessmenl / Dispensing and follow- up in subsequent cycles. Medical Officer(Mo) Initial assessment [history takin& examination including per speculum and bimanual SN) examination by at first AUB ^. visit of all women with r' Refer women to Gynaecologist if (a)menorrhagia + enlarged firm/ irregular uterus or (b)metrorrhagia or (c) intermenstrual bleeding or + (d)menorrhagia normal > yrs. uterine size if woman 40 (e)acute menorrhagia (0 or severe anaemia (g) tenderness on uterine motion Acid 500 mg . Combined Oral Contraceptive o lron (0ral) 60 mg iron elemental /dav. Diclofenac . Tab. 100 mg o Tab. Mefenamic acid 500 mg o 0ral MPA(Medroxy Progesterone Acetate) o Tab. Nor- mobility restricted uterine [h) (i) adnexal mass or fullness / Tele-consultation with Gynaecologist for management ofwomen< 40 yrs. with menorrhagia and Ethisterone acetate 5 mg o lnj DMPA 150mg/ml LNG IUD r normal uterine size without 22 565/694   -     -0/.
0 47 Point ofcare Human Resource/ Service Medicines (Essential List Diagnostics of Level Provider (Levonorgestrel intrauterine device). (by MO only) MBBS severe anaemia. Refer to Gynaecologist for relapse or persistent months complaints after three treatmenL of medical / USG /Hb ,/ Coagula tion profile { Sickling / Thyroid profile r' S. Ferritin Tab. Tranexamic Gynaecologist o Commun ity Health Centre/S DH/DH/ Tertiary care Acid 500 mg o Combined Oral Contraceptive o Iron (Oral) 60 mg elemental iron /dav Parenteral o lron (2Omg/ml, total dose of100mg/dayJ tf Gynaecologist is available at . Tab. Diclofenac 100 mg o Tab. Mefenamic CHC: / Endome trial aspiration/sam pling if needed / D&C if needed / Endome trial Ablarion acid 500 mg . Oral MPA(Madrox Progesterone Acetate) Nor- . Tab. Ethisterone 5 acetate mg o lnl DMPA (Non- hysteroscopic) { Hystere ctomy if needed 150mg/ml LNG IUD . o SERM: Tamoxifen-20mg /Dav Raloxifene- 60mg/Day Bazedoxifene- 20mg/Day 0spemifene- 23 566/694   -     -0/.
0 48 Point of Care Medicines (Essential List of Service Human Resource/ Level Diagnostics Provider Medicines) 60mg/Day lnj.GnRH analogues (Gonadotropin Releasing eg. Inj. Hormone) Leuprolide 3.75mg monthly. uterus 1b. Abnormal Uterine Bl Meno with ASHA/MAS: using checklist ^for AUB . Annual screening ofwomen (Daily Oral iron and calcium with ^D3 supplementation. . elemental iron ^and daily requirement of requirement of Oral iron-60mg Calcium-500mg. Community Sub ^Health / Centre a ASHA/ANM: for ^AUB during o Ensure follow up of women taking treatment home visits. / Tab. Tranexamic Acid 500 mg Gynaecologist and USG are r' Refer to centre where Hwc/ Primary Health Centre/UPH CHO MO available. MBBS / Provide care (including dispensing drugs if M0) during subsequent months to women whose medical treatment has been started by C or ^who have undergone surgical rynaecologist management for AUB. t Parenteral lron therapy ifneeded. Oral/ 24 567/694   -     -0/.
0 49 Gynaecologis o Tab. Tranexamic Acid t Community Health Centre/ Sub Division Hospital /District Hospital/ Tertiary Care / Medical College 500 mg o Combined Oral Contraceptive o lron mg [OralJ 60 elemental iron /day o Parenteral Iron (20m9/ml, total dose of 100mg/day) o Tab. Diclofenac 100 mg Tab. e Mefenamic acid 500 mg o Oral MPA(Medroxy Progesterone Acetate) Tab. o Nor-Ethisterone r' USG {Hb / Coag profile r' Sickling r' Thyroid Profile { S. Ferritin / Endometrial aspiration/Sampling if needed / PCV transfusion if needed r' D&C if needed r' Hysteroscopy / guided biopsy / Hysterectomy if needed acetate 5 mg . Inj DMPA 150mg/ml r LNG IUD SERM: o Tamoxifen-2Omg /Day Raloxifene-60mg/Day Bazedoxifene-20mg/Day 0spemifene-60mg/Day Inj.GnRH analogues IConadotropin Releasing HormoneJ a Tab Ulipristal (As Contraceptive- 30mg/Day and non- contraceptive- 5mg/Day) a 25 568/694   -     -0/.
0 50 Amenorrhoea- irregular ^{bleeding in high} 1c AUB -Metrorrhagia, oligomenorrhoea, family history ^of endometrial risk group (obese, hypertensive,diabetic, /cervical > years ^ofage, OR ^{Persistent dysmenorrhea} cancers), AUB in women 40 ASHA/MAS: using checklist forAUB . Annual screening ofwomen (Daily iron and calcium with ^D3 supplementation. o oral Community Sub ^Health / Centre -60mg iron ^and daily requirement requirement of 0ral iron elemental of Calcium- 500mg. a ASHA/ANM: AUB Ensure follow up of women taking treatment for during o ho CHO MO / UPT and ^USG is / Refer to centre where Gynaecologist available. HWC/ Primary Health Centre/UPH C Community Health Centre/ Sub Division Hospital /District Hospital/ Tertiary o Tab. Tranexamic Acid . USG oHb o Sickling o Thyroid Profile o S. Ferritin . Coag profile . Endometrial Gynaecologis t 500 mg Combined Oral o Contraceptive o Iron (Oral) 60 mg elemental iron /day o Parenteral Iron (20mg/ml, total dose of 100mg/day) Tab. Diclofenac 100 mg o o Tab. Mefenamic acid aspiration/Sampling if needed PCV transfusion o if Care / Medical College needed o D&C if needed . Hysteroscopy / 500 mg Oral MPA(Medroxy o guided biopsy o Conservative Progesterone Acetate) o Tab. Nor-Ethisterone surgical management for Pre- malignant lesions Hysterectomy if needed (including surgical management of endometrial malignancy chemo radiotherapy / follow up as recommended) acetate 5 mg o Inj DMPA 150mg/ml LNG IUD o . SERM: Tamoxifen-20mg /Day Raloxifene-60mg/Day Bazedoxifene-20mg/Day 0spemifene-60mg/Day Inj.GnRH analogues (Gonadotropin Releasing Hormone) 26 569/694   -     -0/.
0 51 Tab Ulipristal ^(As a Contraceptive- and non- 30mg/Day contraceptive- 5mg/Day) 27 570/694   -     -0/.
0 52 i Pelvic t Backache 2. Abnormal t ASHA/MAS: D3 ^tablets and condoms. ,/ Distribution of Oral Iron, ^Calcium with of Infective ^vaginal / Ensure follow up to check for resolution Community Sub ^Health / Centre the acute P Encou of Kit-1,2,6 o Condoms r o Iniectable Ceftriaxone +Vit o Tab Calcium D (Oral) (60mg o lron iron/Day) elemental . Parenteral Iron if needed (2Omglml, total o dose of10Omg/Day) Hwc/ Primary Health Centre/UPH CHO MO Hb VDRL/HBsAg/HIV If CHO is a VIA Iady, provide follow up care in subsequent visits to women who have taken initial care at higher level. C History and examination including per speculum and bimanual examination Ensure treatment of partner r'Hb / VDRL/HBsAg/HIV r' Vaginal discharge examination (Hanging drop and Gram stain) USG r' r' VIA / Pap smear / Colposcopy, S0S biopsy ,/ LLETZ(Large loop Excision of the Transformation Zone) r' Cryotherapy Gynaecologis Kit-1,2,6 o t Condoms o . Ini.Cefotaxime (Lgm/12 hourly and can be extended tp to 2gm/12 hourly) /Cefoperazone . Inj. Metronidazole . Inj.Clindamycin . Tab Calcium tvit D (Oral) e lron o Parenteral Iron o Treatment of partner Community Health Centre/ Sub Division Hospital /District Hospital/ Tertiary Care / Medical College tion ZB 571/694   -     -0/.
0 53 3. Prola ASHA/MAS and ANM: Community cessation. Lifestyle modification, healthy dieg ^smoking Early treatment for chronic ^{cough and} constipation. proper care. Promote insUrudonal delivery for intra-natal Reinforce need for postnatal exercises prolapse. Explain Kegel's exercises for early cHo MO Lifestyle o modification 1st 2nd . and degree - prolapse Pelvic floor exercises . Pessary insertion if necessary by M0 or SN after tele-consultation with Gynaecologist Physiotherapy for o backache Sub Health Centre/HW c/ Primary Health Centre/UPH c o LifesVle modification Community Health Centre/ Sub Division Hospital /District Hospital/ Tertiary Gynaecologis t USG 1st znd degree - and Pelvic floor exercises o 3rd degree Pessary - / Surgical intervention ( VH with Mc Call's with AP repair OR conservative surgery if lady wants to preserve childbearing or is < 40 years of age) . Surgical management Care / Medical College of Vault prolapse and associated stress Urinary Incontinence o Physiotherapy for backache 29 572/694   -     -0/.
0 54 - 4. Lower Abdominal ^Pain ASHA/MAS: with ^{D3 tabs} of ^Oral Iron ^and Calcium o Distribution Community Sub ^Health / Centre Deworming a t iseases of diarrhoeal d for prevention IEC Cou fo P ID Partner treatment r a r' Urine routine and microscopy r' Stool examination Kits-1,2,6 . . Condoms o Tab Calcium tVit cHo MO Refer to Gynaecologist if /no response to treatment or / relapse of symptoms within 6 months or /if with associated fever/ vomiting/ abdominal distension/ breathing difficulty/ abdominal lump/TB in a patient or family member/ within 6 weeks of delivery or within Hwc/ Primary Health Centre/UPH D . Injectable antibiotics (Cefotaxime) o Tab Metronidazole (Oral) o Iron o Parenteral Iron C a month of abortion r' USG r' Urine routine and microscopy / Stool examination / GI endoscopy r' Laparoscopy and SOS surgical intervention Kit-7,2,6 o . Condoms o lni. Cefotaxime Community Health Centre/ Sub Division Hospital /District Hospital/ Tertiary Gynaecologist /Cefoperazone o Inj. Metronidazole o lnj. Clindamycin o Tab Calcium tVit D o Iron (0ral) o Parenteral lron r ATT for genital TB Care / Medical College 30 573/694   -     -0/.
0 55 5 Unheal cervrx Abnormal ASHA/ANM/MAS: of ^{cervical cancer&#x27;} / Warning symptoms suggestive cervical cancer. / Importance ofscreening for lesions' on ^Cervical lntra-epithelial r' Protective effect ofcondoms practices / Safe sex Community Sub ^Health / Centre VIA Hwc/ Primary Health Centre/UPH CHO PAP Smear MO r'vn / Pap smear r' Cervical biopsy (may be sent to higher centre for reporting) r' HPV testing r' Colposcopy r' Cervical biopsy (may be sent to higher centre for reporting) / LEEP,LLETZ, Cryosurgery r' Management of Cervical cancer (Surgery or Radiothera C Community Health Centre/ Sub Division Hospital /District Hospital/ Tertiary Care Gynaecologist 31 574/694   -     -0/.
0 56 - 45 ^years had ^{Hysterectomy before} Post follow up ^of woman who 6 hysterectomy of ASHA/MAS: D3 / Distribution of oral lron and ^Calcium with problems ^{and care.} / IEC about Post-menopausal Community + Sub Health Centre Hwc/ PHC/Non FRU CHC dier im of exercise and healthY / Counselling on . Tab Calcium t Vit D o lron (Oral) o Parenteral lron . Vaginal Estrogen oHb Profile o Lipid r S. creatinine CHO MO creams after tele-consultation with the Gynaecologist o USG .Hb o Thyroid Profile Profile o Lipid S. o creatinine o ECG Bone Density o Mineral r Tab Calcium I Vit D Iron (Oral) o Iron o Parenteral . Vaginal Estrogen Community Health Centre/ Sub Division Hospital /District Hospital Tertiary Gynaecologist creams Oral Estrogen - o Progesterone for HRT if indicated o Bisphosphonates o Tab Tibolone testing Care / Medical College (2.5mg/day) 5Z 575/694   -     -0/.
0 57 2 Annexure Basic Facts on Hysterectomy About Hyste rectomV a pelvic organ of the female ^reproductive system ^where the fetus Uterus is midline pregnancy. The surgical procedure of ^removal ofthe ^uterus is called develops during is a by ^a under hysterectomy. Hysterectomy major surgery done trained rynaecologist removal ^{of the} regional or general anaesthesia. An abdominal hysterectomy involves hysterectomy is ^performed uterus through an incision in the lower abdomen. When a hysterectomy. Laproscopic through an incision in vagina it is called vaginal is cervix are removed completely with the help of Hysterectomy where the uterus and incisions on the abdomen. laproscope & laprosopic instruments through small . A total hysterectomy is the removal ofthe uterus and cervix. the ovaries and fallopian tubes, r When a hysterectomy includes removal ofboth procedure is Salpingo-0ophorectomy. the called hysterectomy with Bilateral Hvsterectomy with or without Oophorectomy The various indications for ovarian removal at the time of hysterectomy include genital malignancies (ovarian cancer, cancer, cervical cancer, metastasis tract uterine from and non-genital tract malignanciesJ, removal of ovaries tubes in women genetically susceptible to ovarian cancer, ectopic pregnancy, ovarian abscess, ovarian performed endometriosis etc. ln many non-cancerous conditions oophorectomy is with possibility the aim ofreducing the of ovarian cancer in the future. Risk, benefits, and patient alternatives need to be discussed with the before surgery. Patients must be informed possible ofthe complications and the long-term effects ofdecreased hormone levels due to ovarian removal. Unnecessary hysterectomv There is a fear that hysterectomy is done without reason. Patients seek more can than one opinion before taking be decision. Many rynaecological conditions can managed conservatively without the need for surgical intervention and hysterectomy should always be reserved as the last option. Few cases where hysterectomies can be avoided are o Abnormal uterine bleeding o Fibroid . Completion of family r Precondition for employment .) -) 576/694   -     -0/.
0 58 a Fear of cancer ^as a method of ^treatment Hysterectomy as ofuterine can be ^performed in ^{various conditions} such treatment Hysterectomy various ^common cancer, ovarian cancer, some cases ofcervical ^{cancer, and} bleeding ^fibroids, noncancerous gynaecological conditions like abnormal uterine prolapse, pelvic pain ^etc&#x27; that ^lead to adenomyosis, endometriosis, uterovaginal chronic and stress amongst levels of pain, discomfort, uterine bleeding emotional varying a recovery time ^and is ^only women. A hysterectomy is a major operation ^with long is considered after less invasive treatments have been ^{tried. Although hysterectomy} nonsurgical definitive treatment for many conditions, often the rynaecological should always be attempted in elective cases. alternatives hysterectomy can ^be done after ^{all nonsurgical options} have Conditions for which been tried (lumps in cause ^pain, bleeding or otler ^problems a. Uterine fibroids uterus) that Thickening ofthe uterus adenomyosis, endometrial hyperplasia etc. b. - Uterine ^prolapse, which is a sliding ofthe uterus from ^its normal position into the c. canal vaginal cervix, or ovaries d. Cancer ofthe uterus, vaginal bleeding+ e. Abnormal pelvic pain f. Chronic A hysterectomy may not be the best option for all women. It shouldn't be performed on women who still want to have children unless no other alternative are possible. Luckily, many conditions that can be treated with a hysterectomy may also be ways. For instance, hormone therapy can be used to treated in other can be treated with other types of surgery that treat endometriosis. Fibroids spare the uterus. Hysterectomy should alwavs be the last option. Side Complications and effects a Immediate Complications include heavy bleeding during or after damage and surgery, risk of blood transfusion, to surrounding organs nerves, blood vessels like the bladder, uretlra, uterine aftery and problems blood clots in the legs and lungs , breathing or problems due to anaesthesia persistent Short term-fevers and chills, nausea and vomiting, infection at the incision site, excessive bleeding requirement blood of transfusion, difficulty with bowel function, difficulty voiding pain which is not resolving lniury to adjacent bladder, organs [bowel, ureter), lnjury to nerves, chest pain, difficulty breathing lower extremity, or calf pain and anesthesia related complications. 34 577/694   -     -0/.
0 59 (bladder due ^to cystocele formation Long-term- Bladder dysfunction incontinence (lnvoluntary prolapse through the vaginal wall), stress and passage of urine), formation of enterocele and rectocele fbowel wall), ^vaginal vault ^prolapse. rectum prolapsing through ^the vaginal induced Long term effects of decreased hormone levels- ^surgically the flashes (sudden feeling ^of warmth in menopause including hot face, ^neck and body which is usually most ^{intense over} the upper UTI, mood chest), night sweats, insomnia, vaginal dryness, recurrent and changes, irritability, increased bone loss ^leading to ^osteoporosis cardiac disease. a a hvsterectomv Changes women can expect after women attains a surgical menopause so there will ^{be no} menstrual The periods.lf the ovaries have been removed along with a hysterectomy, flashes, sweatin& vaginal there may be menopausal symptoms like hot dryness, mood swings etc as well as increased chances of developing diseases, etc. osteoporosis, dyslipidemia, cardiovascular stroke If ovaries are retained, menopause is experienced at a ^younger than average age. a There will be a symptomatic relief of symptoms. Some changes after hysterectomy. There women may experience mood may be grief and possibly depression over the loss of fertility, loss of interest in food & letharry. a lack interest sex after a Some women have vaginal dryness or of in hysterectomy, especially if the ovaries have been removed. a If both ovaries are removed, this may put the woman at higher risk for certain conditions such as: bone loss, heart disease, and urinary incontinence of urine)1. Ieaking Issues relating menstruation to Menstruation is required to be managed in a healthy and hygienic manner. One of the huge challenges in our society is the inability to deal with blood flow hygienically during get menstruation.A large number of hysterectomies are done to rid of menstruation good without application of safer medical methods of treatmenL Here, counselling by a provider and a trained counsellor becomes very importanl ASHA, Anganwadi worker a and ANM can all popularize this by using campaign format 35 578/694   -     -0/.
0 60 Annexure 3 Guidance on Conducting Audits of Hysterectomies Medical audits are utilised to monitor the appropriate use of specific procedures. ln the case of hysterectomy, ensuring regular audits may be necessary areas where in unnecessary use is suspected. The guidance below explains the process and an use for audit. Who should conduct the assessment? setting up of a Hysterectomy - Audit committee Medical audit is best conducted by more than one person e.g. a technical expert and someone with social sciences expertise. A guideline practitioners for will help them to provide services that are ethically and technically correct in the social setting in which the patient practitioner exists and practices. What can form part ofthe audit for unnecessary hysterectomy? 1, Patient Profile a. Age b. Number of living children Socio economic status c. d. Education Cultural beliefs e. Occupation f. g. Area ofresidence Distance hospital h. from Eligibility of patients 2. for hysterectomy o Is the indication for hysterectomy matching with the signs and symptoms of the actual disease from history taking clinical examinatio4 pathological and radiological findings? Is the o patient really eligible for hysterectomy age group, cause, menstrual - symptoms marital status, desirous of fertility etc. o Is the patient prepared for anaesthesia and hysterectomy medically - and psychological fit? 3. Use of alternative and effective medical treatment r Ifthe condition was benign (not cancerJ, were alternative non-surgical medical / treatments tried o Was counselling on alternative treatment modalities done o What was the alternative treatment provided and for how long was it used e.g. . Polyp : Polypectomy . Adenomyosis : LNG IUS/Oral hormonal therapy/Others . Leiomyoma-Myomectomy/Hysteroscopic resection/Uterine artery 36 579/694   -     -0/.
0 61 embolizarion/cnRH analogues Ulipristal acetate DMpA IUS / /tnj. /LNc . progesterone Endometrial Hyperplasia - High dose . CIN: Conization/LEEP/LLETZ Treatment of Coagulopathy ' . AUB due to progesterone Ovulatory dysfunction: therapy . Utero-vaginal prolapse - pessary ' Obstenical Haemorrhage : Uterine artery embolization/ Compression sutures/ Uterine balloon tamponade was the effectiveness ofalternative treatment assessed before deciding on hysterectomy If yes, was it documented in the patient,s case notes with necessary supportive documents 4. Choice of surgical method o What was the rationale for selecting the type of surgical procedure o Was the patient made aware about risks and outcomes of the selected procedure? o was comparison of costs of recommended procedures done - abdominal, vaginal and laparoscopic hysterectomy? 5. Ethical issues o was the decision on selecting the treatment method, particurarry if a surgical procedure was recommended, based on invorved and informed consent ofthe patient o Was primary care for the gmaecological condition available to the patient o Was choice ofsecond or expert opinion available to the patient . Was there any conflict of interest by the provider i.e. was provider opinion influenced by personal interest e.g. rearning more about a procedure ( training or earning situations ) monetary benefit from patient or insurance agency o whether the audit is interfering with professional freedom of the practitioner or with doctor patient relationship in that particular setting 6. How was the Hysterectomy conducted? Was it performed abdominally, vaginally or laparoscopically? Approach will depend on indications for surgery, nature of disease, surgeon and patient preferences 7 Why was the hysterectomy conducted? The reasons can range from benign conditions ofthe uterus to malignancies of the genital tract as well as obstetric reasons Common Gvnaecological Reasons 37 580/694   -     -0/.
0 62 . Uterine fibroids - depends on site, size and symptom . Chronic pelvic infection o Chronic pelvic pain o Abnormal Uterine Bleeding: polyps o o Adenomyosis,endometriosis o Endometrial - causes Malignancy, Hyperplasia and other o Cancer ofthe ovaries, cervix, fallopian tubes. o Premaligrant lesions of cervix. o latrogenic o Utero-vaginal prolapse 0bstetric Reasons o Atonic Post-partum Haemorrhage with/without placenta praevia o Traumatic Post-partum Haemorrhage o Adherent placenta with/without placenta praevia o Sepsis o Rupture Uterus o Intractablepost-partumhaemorrhage Were 8' tlere intra-operative or post-operative complications during/folrowing hysterectomy and were these documented? 9' was there need for correction of anaemia by brood transfusion/ parenterar iron? 10. Was the Hysterectomy covered by an insurance scheme? 11. What was the cost incurred due to hysterectomy, including related interventions/treatment beforg during and after the procedure? 3B 581/694   -     -0/.
0 63 Annexure 4 VARIOUS MODALITIES OF TREATMENT AVAILABLE FORAUB/ DUB 1. Medical treatment for dysfunctional uterine bleeding Medical treatment options for DUB include tranexamic acid, nonsteroidal anti- inflammatory drugs (NSAIDs), combined oral contraception pill, progestogen, danazol and gonadotropin-releasing hormone analogues The' [GnriH-a). effictive"neis of the reported medical therapy DUB for has been evaluated and reviewed in systematic reviews in the Cochrane Library. Tranexamic acid Antifibrinolytic tranexamic proven acid has to be more effective than placebo, NSAIDs, progestogen in the luteal phase of menstrual cycle, or ethamsylate when subscribed to women with DUB, without any serious adverse effects . A reduction in menstrual flow by 34-590/o has been reported by wellington and wagstaff which is quite impressive. , However, this drug is mainly indicated for acute or short-term use and not as a definite treatment for DUB. The main problem with the administration of tranexamic acid for the treatment of DUB is the potential risk of thromboembolic disease due to its antifibrinolytic effecr Although this is always an issue, especially in cases of severe anemia, it seems that the risk does not reach a statistical significance. Nonsteroidal anti-inflammatory drugs Prostaglandins are found high in concentrations in the endometriar shedding. Nonsteroidal anti-inflammatory drugs inhibit prosaglandin synthesis and decrease menstrual blood loss. NSAIDs are quite effective in cases of DUi compar"a io prr.Luo, but they are less effective than iither tranexamic acid, danazol, ,i. rlro'.c"rir intrauterine system. Combined oral contraceptive pill The combined oral contraceptive pill is another effective alternative treatment for DUB, offering at the same time contraception to women. It reduces menstrual urooa iors, uut there are not enough data to determine its value in comparison to other drugs.io, it seems reasonable to offer a comb-ined oral contraceptive pill in youni *omen [coc) suffering from DUB who also seek for contraception at the same time. 39 582/694   -     -0/.
0 64 Progestogens The administration of progestogens for the treatment of anovulatory DUB was always a tempting alternarive for physicians, in order to restore the natural cycle of endometrial growth and shedding. phase progestogens The oral luteal do not seem to be more advantageous over other hormonal medical treatments or levonorgestrel-releasing inrrauterine device. A long-term progestogen administration of is sometimes followed by as severe side effects, such water retention and hirsutism, depending on the type anddose of progestin. Danazol-gonadotropin-releasing hormone analogues Danazol and the GnRH analogues were found as highly effective agents for DUB compared to other medical treatments However, the administration of danazol or GnRH-a is limited due to their strong side effects. Long-term administration of danazol may cause hirsutism while GnRH-a is associated with irreversible bone loss when used for more than 6 months. Thus, their utility is restricted mainly for short-term use, especially in cases ofsevere anemia, until further treatment is decided. 2, Levonorgestrel-releasing intrauterine device Another medical method the for treatment of DUB is the levonorgestrel-releasing intrauterine system (Mirena@). It was originally developed as a contraceptive method, but it has been proven quite effective in the treatment of DUB, so t}le device acquired approval for that indication too. Its efficacy is based on the continuous local release of the progestogen (levonorgestrel) within the uterine cavity, which suppresses endometrial growth. Studies report reduction of blood loss in menstrual cycles up to 97o/o, with its maximum efficacy 1 year after insertion. The majority of women with Mirena bleed only for 1 day or experience just spotting during their period, while 15yo ofthem become amenorrhoeic. There are two trials comparing levonorgestrel intrauterine (luD) device with medical treatment, two trials to rranscervical resection of the endometrium and three trials comparing Mirena@ with balloon ablation. Mirena was found superior to ryclical progestogens and mefenamic acid, but is significantly less effective than endometrial ablation in reducing blood loss. Interestingly, levonorgestrel IUD was found more cost effective than hysterectomy in Hurskainen et al.,s trial. 3, Surgical treatment for dysfunctional uterine bleeding In cases of DUB resistant to medical treatment, physicians should offer to women an alternative surgical treatmenl In such patients, one could choose between endometrial ablation techniques and hysterectomy, taking into consideration patient's age, physical condition, and will. 40 583/694   -     -0/.
0 65 as an treatment ^option in women Dilatation and curettage, which is offered alternative periods, results ⁱⁿ a ^temporary reduction of with excessive blood loss during menstrual procedure, therefore ^it should not be ^proposed blood loss for the first month after the DUB. and performed in women suffering from Endometrial ablation techniques Since Ashermann 1948 described for the first time the association between in pregrancies, amenorrhea and dilatation and curettage for termination of several investigators have studied the possibility ofa controlled destruction of the basal layer of the endometrium in order to treat abnormal uterine bleeding. Several methods have been developed from the early 1980s for the ablation of the endometrium and have been studied in cohort studies and randomized controlled trials. Basically, all these methods are divided in tvvo large groups with a criterion, the need of direct visualization of the endometrial cavity. First-generation endometrial ablation techniques First-generation endometrial ablation techniques are based on direct visualization of the endometrial cavity with a hysteroscope. Three methods were developed since the late 1980s, and their efficacy were studied and compared techniques to other by many investigators. Before the application of each technique, endometrial thinning was necessary by using GnRH-a or danazol. Hysteroscopic laser ablation The first laser method was a neodymium-YAG laser, which destroyed the endometrium through a hysteroscope . 0bservational studies have reported a satisfaction rate up to 97o/o and amenorrhea rates ranging beByeen 25o/o and 600/o after hysteroscopic laser . Failure rates varied between 7o/o and,2!o/o same ablarion [HLA) in the studies. There is only one prospective randomized comparing trial laser ablation with transcervical resection ofthe endometrium reporting 230lo amenorrhea rate and 900/o rate. satisfaction Despite the promising results of its use, the equipment's high cost and extended learning curve remain obstacles for its wide application. Transcervical endometrial resection The wide use ofa resectoscope in grnaecological operations allowed its application as a method for treatment of DUB . Transcervical endometrial resection (TCRE) has been shown to be an effective and safe method for treating DUB . TCRE was tested in nonrandomized prospective studies, which reported a satisfaction rate between B5yo and 87o/o and an amenorrhea rate varying 460/o. TCRE comparable up to is to other hysteroscopic endometrial ablation techniques in terms of amenorrhea and satisfaction rates. Direct visualization of the endometrial cavity and the possibility of treating concomitant patholory endometrial at the time of endometrial ablation remain themajor advantages of the method. Rollerball endometrial ablation 4t 584/694   -     -0/.
0 66 The technique was developed in 1989 in Australia by Vancaillie and soon became quite popular due to its relative simplicity and excellent results. Studies report comparable results from its application to the other two first-generation ablation techniques (satisfaction 94o/o 35o/o). rate up to and amenorrhea rate varying between 29o/o and Rollerball endometrial ablation requires less operative time and shorter learning curve TCRE compared to and HLA. Studies evaluating first-generation ablation techniques revealed quite impressive results regarding their effectiveness, treating three fourths of the women suffering fromDUB, proceed who would otherwise to hysterectomy in terms of definite treafmenL They are acknowledged to be the "gold standard" by which other, newer procedures arejudged. HLA and rollerball ablation are considered safer methods than TCRE, while resection of the endometrium caused more of the serious and possibly fatal complications, which include uterine perforation and bleeding bowel injury visceral burn, and hyponatremic encephalopathy with cerebral edema. Second-generation endometrial ablation techniques Many endometrial ablation devices have been developed in the early 1990s for the treatment DUB categorized of and as second-generation ablation techniques. Their application did not require the use of a hysteroscope, so the advantage of a direct visualization of the endomeffial cavity no longer existed. Therefore, endometrial biopsy prior to ablation is a prerequisite. mandatory Every method consists of a different device which, by means different (hot liquid, laser, bipolar energy, ultrasound, microwaves, heating balloons, or cryoablation), causes selective destruction of the endometrial layer. These devices require less skills of the surgeon, as they are very simple to use, so is the learning curve smaller. The operation time is shorter, the anesthesia/analgesia can become minimal, and the complicationrate is reduced. In some of these techniques, a preoperative thinning of the endometrium with GnRH-a or danazol is not necessary, in contrast to all first-generation ablation techniques. Thermal balloon endometrial ablation The technique consists of a balloon for insertion in the endometrial a cavity and generator. balloon is After insertion, the filled with hot liquid that causes a desfructive thermal effect to the surrounding endometrium. The Thermablate thermal balloon was developed in 2004, and since then, various autlors have studied the application results of this device. Amenorrhea rate ranges between 22.2o/o and 35%o a failure with rate varying between 3o/o and S.So/o . Endometrial ablation by hysteroscopic instillation of hot saline (hydrotherm ablator) 42 585/694   -     -0/.
0 67 as second- categorized a hysteroscopically' is although applied This technique, . ;;;;.;il; "nJorn"t ""ur"tion 90'C ^is infused saline of techriique. ^{Externalty_heated} i"r hy-steroscope. The of ^{a diagnostic} sheath uterine cavity through the external irJ,t. the thus ^{preventing flow.through} is ^less than 45 ^mmHg ,sea ^ror the ^infusioi ;;;r the ablation of view-, ^the hot ^saline causes hysteroscopic tubes. ^Under direct irri"pi* several method is ^tested in experience ^of the The ^application endometrium. to ^{rollerball&#x27;} controlled trial ^compared one ^randomized sUdies ind ⁱⁿ oUr"-rtionrf up rate ^up to ^940lo&#x27; and ^{satisfaction rate} up ^to 530/0, cure rates ^are reported Amenorrhea . to 98olo (MEA) ablation Microwave endometrial to ^{first-generation} endometrial ablation system has been compared The microwave in with ^similar results in ^randomized trials and rollerbailJ ablative techniques ITCRE \ ^Iow years surgery ^wi 10 following and satisfaction .ri"r, lerms of amenorrhea "u"n co.pticationrates.ThereisalsoonerandomizedcontrolledtrialcomparingMEAand and menstrual ^scores results ⁱⁿ relation to showing ^similar ttr"irnrr balloon ^ablation, satisfaction. (ELITT) thermal therapy Endometrial laser ^intrauterine causes ^{endometrial ablation} Donnez et ^{al&#x27; in 1996} and was developed by The technique is prior ^to laser ^application endometrium . ^Preparation ofthe by laser ^{photocoagulation} a ^prospective observational has ^{been evaluated} in The ^technique consiaerla n"."riry. 90%o at ^{12 months after treatment, while} rate was reported up ^to study. satisfaction trial ^comparing controlled 710lo ^. There ^{is only} one randomized amenorrhea rate ^was 23010, respectively 56010 ^and at 12 ^{months amenorrhea rates of} ELITT and TCRE, reporting ablation Cryo-endometrial of gas, achieves ^a temperature -90 by ^a cooling which is achieved Endometrial ablation has ^been evaluated in _1.00.c The ^treatment within the ^{endometrial cavity.} to 28% ^and with ^encouraging results famenorrhea observational studies p.orp*riu" . satisfaction up to 91%) (Novasure) controlled endometrial ablation Bipolar impedance single-use ^bipolar ablation frequency generator and a of a radio The device consists electrode, which expandable bipolar probe. The probe consists of ^a three-dimensional a is also vacuum cavity, ^when opened' There in touch ^with the entire endometrial comes pumpwithinthegenerator,whichprovidescontinuo.ussuctionoftheendometriallining is ^not generally of the ^endometrium preoperative preparation ind debris; therefore, power of50.O ^of 500 ^KHz and ^has a cutoff ^limit The ^generator ope;ates at needed. immediately ^the tissue layer ^is reached, impedlnce. Once ^the myometrial Ussue off' O, the ^{generator automatically} switches increases to ⁵⁰ and impedance and ^women prospective observational studies has ^{been evaluated} in This method a rate ^{of up} to ^5870, and failure of up ^to B7ok, ^an amenorrhea reported a satisfaction ^rate postablation 3 ^years after treatment, while ^{amenorrhea rate at} .aie of up to 3o/o ^lyear