Risk of melanoma in women with endometriosis: A Scottish national cohort study.

OBJECTIVE: To explore the risk of melanoma in women with endometriosis. STUDY DESIGN: A retrospective cohort study using Scottish national population-based data was conducted. The study comprised 281,937 women with nearly 5 million person years (4,923,628) of follow up from 1981 to 2010. 17,834 women with a new surgical diagnosis of endometriosis were compared with 83,303 women with no evidence of endometriosis at laparoscopy, 162,966 women who underwent laparoscopic sterilisation and 17,834 age-matched women from the general population to determine the risk of melanoma. Cox proportional hazards regression was used to calculate crude and adjusted Hazards ratios with 95 % Confidence Intervals. RESULTS: Women with endometriosis had a significantly higher risk of melanoma when compared to women with no evidence of endometriosis at laparoscopy (HR 1.59, 95 % CI 1.19-2.13), women who had undergone laparoscopic sterilisation (HR 1.82, 95 % CI 1.39-2.40) and age-matched women from the general population (HR 1.63, 95 % CI 1.08-2.45). CONCLUSION: A diagnosis of endometriosis was associated with an increased risk of developing melanoma compared to those without endometriosis. These findings highlight the need for further research to explore shared pathways in the pathogenesis of the two conditions. It is important to acknowledge that the absolute increase in the risk of melanoma in women with endometriosis remains low, which should be considered when counselling women.

Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).

OBJECTIVE: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN: Randomised controlled trial. SETTING: Thirty-three UK hospitals. POPULATION: Women having surgery for recurrent prolapse. METHODS: Women recruited using remote randomisation. MAIN OUTCOME MEASURES: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.

Surgical management of pelvic organ prolapse.

Despite pelvic organ prolapse being a universal problem experienced in nearly 50% of parous women, the surgical management of vaginal prolapse remains an enigma to many, with wide variation in the rates and types of intervention performed. As part of the 6th International Consultation on Incontinence (ICI) our committee, charged with producing an evidence-based report on the surgical management of prolapse, produced a pathway for the surgical management of prolapse. The 2017 ICI surgical management of prolapse evidence-based pathway will be presented and summarized. Weaknesses of the data and pathway will be discussed and avenues for future research proposed.

Impact of endometriosis on risk of further gynaecological surgery and cancer: a national cohort study.

OBJECTIVE: To evaluate the long-term risk of further gynaecological surgery and cancer in women with endometriosis. DESIGN: Cohort study. SETTING: Scotland. PARTICIPANTS: 281 937 women with nearly 5 million person years (4 923 628) of follow up from 1981 to 2010. METHODS: In this national population-based study we compared 17 834 women with a new surgical diagnosis of endometriosis with 83 303 women with no evidence of endometriosis at laparoscopy, 162 966 women who underwent laparoscopic sterilisation, and 17 834 age-matched women from the general population. Cox proportional hazards regression was used to calculate crude and adjusted hazard ratios with 95% confidence intervals. MAIN OUTCOME MEASURES: Risk of further gynaecological surgery, number and type of repeat surgery and time to repeat surgery from the diagnosis of endometriosis. Cancer outcomes included subsequent risk of all cancer, gynaecological and non-gynaecological cancers. RESULTS: Women with endometriosis had a significantly higher risk of further surgery when compared with women with no evidence of endometriosis at laparoscopy [hazard ratio (HR) 1.69, 95% (confidence interval) CI 1.65-1.73], women who had undergone laparoscopic sterilisation (HR 3.30, 95% CI 3.23-3.37) and age-matched women from the general population (HR 5.95, 95% CI 5.71-6.20). They also have an increased risk of ovarian cancer when compared with general population counterparts (HR 1.77, 95% CI 1.08-2.89) or those with laparoscopic sterilisation (HR 1.75, 95% CI 1.2-2.45). CONCLUSION: Women with surgically diagnosed endometriosis face an increased risk of multiple surgery. They have a higher chance of developing ovarian cancer in comparison with the general population and women with laparoscopic sterilisation. TWEETABLE ABSTRACT: Women with endometriosis face an increased risk of recurrent surgery and developing ovarian cancer.

Pregnancy outcomes in women with endometriosis: a national record linkage study.

OBJECTIVE: To determine pregnancy outcomes in women with endometriosis. DESIGN: A national population based cohort study using record linkage. SETTING: Scotland. PARTICIPANTS: A cohort of 14 655 women followed up over a 30-year period (1981-2010). METHODS: In a nationwide Scottish study, we compared pregnancy outcomes in 5375 women with surgically confirmed endometriosis with outcomes in 8710 women without endometriosis who were pregnant during the same time period. Data were analysed using univariable and multivariable logistic regression after adjusting for confounding factors. MAIN OUTCOME MEASURES: Outcome measures evaluated included miscarriage, ectopic pregnancy, stillbirths and other pregnancy complications such as hypertensive disorders of pregnancy, antepartum and postpartum haemorrhage, operative delivery and preterm births. The outcomes were presented as adjusted odds ratios (OR) with 95% confidence intervals (CI). RESULTS: On multivariable analysis, after adjusting for age, parity, socio-economic status and year of delivery, women with endometriosis when compared to women without endometriosis, had a significantly higher risk of early pregnancy complications with adjusted OR (95% CI) of 1.76 (1.44, 2.15) and 2.70 (1.09, 6.72) for miscarriage and ectopic pregnancy, respectively. A previous diagnosis of endometriosis was associated with a significantly increased risk of [adjusted OR (95% CI)] placenta praevia [2.24 (1.52, 3.31)], unexplained antepartum haemorrhage [1.67 (1.39, 2.00)], postpartum haemorrhage [1.30 (1.61, 1.46)] and preterm births [1.26 (1.07, 1.49)] in pregnancies progressing beyond 24 weeks. CONCLUSION: Endometriosis predisposes women to an increased risk of early pregnancy loss and later pregnancy complications. TWEETABLE ABSTRACT: Endometriosis predisposes women to an increased risk of early pregnancy loss and later pregnancy complications.

Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial.

OBJECTIVE: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall). DESIGN: Follow up of a prospective, double-blind randomised controlled trial at 5 years. SETTING: A teaching hospital in the UK. POPULATION: A total of 320 women eligible for and requesting endometrial ablation. METHODS: Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database. MAIN OUTCOME MEASURES: The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery. RESULTS: Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%). CONCLUSIONS: At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.

Hysterectomy, endometrial ablation and Mirena® for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis.

OBJECTIVE: The aim of this project was to determine the clinical effectiveness and cost-effectiveness of hysterectomy, first- and second-generation endometrial ablation (EA), and Mirena® (Bayer Healthcare Pharmaceuticals, Pittsburgh, PA, USA) for the treatment of heavy menstrual bleeding. DESIGN: Individual patient data (IPD) meta-analysis of existing randomised controlled trials to determine the short- to medium-term effects of hysterectomy, EA and Mirena. A population-based retrospective cohort study based on record linkage to investigate the long-term effects of ablative techniques and hysterectomy in terms of failure rates and complications. Cost-effectiveness analysis of hysterectomy versus first- and second-generation ablative techniques and Mirena. SETTING: Data from women treated for heavy menstrual bleeding were obtained from national and international trials. Scottish national data were obtained from the Scottish Information Services Division. PARTICIPANTS: Women who were undergoing treatment for heavy menstrual bleeding were included. INTERVENTIONS: Hysterectomy, first- and second-generation EA, and Mirena. MAIN OUTCOME MEASURES: Satisfaction, recurrence of symptoms, further surgery and costs. RESULTS: Data from randomised trials indicated that at 12 months more women were dissatisfied with first-generation EA than hysterectomy [odds ratio (OR): 2.46, 95% confidence interval (CI) 1.54 to 3.93; p = 0.0002), but hospital stay [WMD (weighted mean difference) 3.0 days, 95% CI 2.9 to 3.1 days; p < 0.00001] and time to resumption of normal activities (WMD 5.2 days, 95% CI 4.7 to 5.7 days; p < 0.00001) were longer for hysterectomy. Unsatisfactory outcomes associated with first- and second-generation techniques were comparable [12.2% (123/1006) vs 10.6% (110/1034); OR 1.20, 95% CI 0.88 to 1.62; p = 0.2). Rates of dissatisfaction with Mirena and second-generation EA were similar [18.1% (17/94) vs 22.5% (23/102); OR 0.76, 95% CI 0.38 to 1.53; p = 0.4]. Indirect estimates suggested that hysterectomy was also preferable to second-generation EA (OR 2.32, 95% CI 1.27 to 4.24; p = 0.006) in terms of patient dissatisfaction. The evidence to suggest that hysterectomy is preferable to Mirena was weaker (OR 2.22, 95% CI 0.94 to 5.29; p = 0.07). In women treated by EA or hysterectomy and followed up for a median [interquartile range (IQR)] duration of 6.2 (2.7-10.8) and 11.6 (7.9-14.8) years, respectively, 962/11,299 (8.5%) women originally treated by EA underwent further gynaecological surgery. While the risk of adnexal surgery was similar in both groups [adjusted hazards ratio 0.80 (95% CI 0.56 to 1.15)], women who had undergone ablation were less likely to need pelvic floor repair [adjusted hazards ratio 0.62 (95% CI 0.50 to 0.77)] and tension-free vaginal tape surgery for stress urinary incontinence [adjusted hazards ratio 0.55 (95% CI 0.41 to 0.74)]. Abdominal hysterectomy led to a lower chance of pelvic floor repair surgery [hazards ratio 0.54 (95% CI 0.45 to 0.64)] than vaginal hysterectomy. The incidence of endometrial cancer following EA was 0.02%. Hysterectomy was the most cost-effective treatment. It dominated first-generation EA and, although more expensive, produced more quality-adjusted life-years (QALYs) than second-generation EA and Mirena. The incremental cost-effectiveness ratios for hysterectomy compared with Mirena and hysterectomy compared with second-generation ablation were £1440 per additional QALY and £970 per additional QALY, respectively. CONCLUSIONS: Despite longer hospital stay and time to resumption of normal activities, more women were satisfied after hysterectomy than after EA. The few data available suggest that Mirena is potentially cheaper and more effective than first-generation ablation techniques, with rates of satisfaction that are similar to second-generation techniques. Owing to a paucity of trials, there is limited evidence to suggest that hysterectomy is preferable to Mirena. The risk of pelvic floor surgery is higher in women treated by hysterectomy than by ablation. Although the most cost-effective strategy, hysterectomy may not be considered an initial option owing to its invasive nature and higher risk of complications. Future research should focus on evaluation of the clinical effectivesness and cost-effectiveness of the best second-generation EA technique under local anaesthetic versus Mirena and types of hysterectomy such as laparoscopic supracervical hysterectomy versus conventional hysterectomy and second-generation EA. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system (Mirena) for treatment of heavy menstrual bleeding: cost effectiveness analysis.

OBJECTIVE: To undertake a cost effectiveness analysis comparing first and second generation endometrial ablative techniques, hysterectomy, and the levonorgestrel releasing intrauterine system (Mirena) for treating heavy menstrual bleeding. DESIGN: Model based economic evaluation with data from an individual patient data meta-analysis supplemented with cost and outcome data from published sources taking an NHS (National Health Service) perspective. A state transition (Markov) model was developed, the structure being informed by the reviews of the trials and clinical input. A subgroup analysis, one way sensitivity analysis, and probabilistic sensitivity analysis were also carried out. POPULATION: Four hypothetical cohorts of women with heavy menstrual bleeding. INTERVENTIONS: One of four alternative strategies: Mirena, first or second generation endometrial ablation techniques, or hysterectomy. MAIN OUTCOME MEASURES: Cost effectiveness based on incremental cost per quality adjusted life year (QALY). RESULTS: Hysterectomy is the preferred strategy for the first intervention for heavy menstrual bleeding. Although hysterectomy is more expensive, it produces more QALYs relative to other remaining strategies and is likely to be considered cost effective. The incremental cost effectiveness ratio for hysterectomy compared with Mirena is £1440 (€1633, $2350) per additional QALY. The incremental cost effectiveness ratio for hysterectomy compared with second generation ablation is £970 per additional QALY. CONCLUSION: In light of the acceptable thresholds used by the National Institute for Health and Clinical Excellence, hysterectomy would be considered the preferred strategy for the treatment of heavy menstrual bleeding. The results concur with those of other studies but are highly sensitive to utility values used in the analysis.

Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results.

OBJECTIVE: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids. DESIGN: Pragmatic, open, multicentre, randomised trial. SETTING: Twenty-seven participating UK secondary care centres. SAMPLE: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment. METHODS: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine). MAIN OUTCOME MEASURES: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention. RESULTS: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years. CONCLUSIONS: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.

Hysterectomy, endometrial destruction, and levonorgestrel releasing intrauterine system (Mirena) for heavy menstrual bleeding: systematic review and meta-analysis of data from individual patients.

OBJECTIVE: To evaluate the relative effectiveness of hysterectomy, endometrial destruction (both "first generation" hysteroscopic and "second generation" non-hysteroscopic techniques), and the levonorgestrel releasing intrauterine system (Mirena) in the treatment of heavy menstrual bleeding. DESIGN: Meta-analysis of data from individual patients, with direct and indirect comparisons made on the primary outcome measure of patients' dissatisfaction. DATA SOURCES: Data were sought from the 30 randomised controlled trials identified after a comprehensive search of the Cochrane Library, Medline, Embase, and CINAHL databases, reference lists, and contact with experts. Raw data were available from 2814 women randomised into 17 trials (seven trials including 1359 women for first v second generation endometrial destruction; six trials including 1042 women for hysterectomy v first generation endometrial destruction; one trial including 236 women for hysterectomy v Mirena; three trials including 177 women for second generation endometrial destruction v Mirena). Eligibility criteria for selecting studies Randomised controlled trials comparing hysterectomy, first and second generation endometrial destruction, and Mirena for women with heavy menstrual bleeding unresponsive to other medical treatment. RESULTS: At around 12 months, more women were dissatisfied with outcome with first generation hysteroscopic techniques than with hysterectomy (13% v 5%; odds ratio 2.46, 95% confidence interval 1.54 to 3.9, P<0.001), but hospital stay (weighted mean difference 3.0 days, 2.9 to 3.1 days, P<0.001) and time to resumption of normal activities (5.2 days, 4.7 to 5.7 days, P<0.001) were longer for hysterectomy. Unsatisfactory outcomes were comparable with first and second generation techniques (odds ratio 1.2, 0.9 to 1.6, P=0.2), although second generation techniques were quicker (weighted mean difference 14.5 minutes, 13.7 to 15.3 minutes, P<0.001) and women recovered sooner (0.48 days, 0.20 to 0.75 days, P<0.001), with fewer procedural complications. Indirect comparison suggested more unsatisfactory outcomes with second generation techniques than with hysterectomy (11% v 5%; odds ratio 2.3, 1.3 to 4.2, P=0.006). Similar estimates were seen when Mirena was indirectly compared with hysterectomy (17% v 5%; odds ratio 2.2, 0.9 to 5.3, P=0.07), although this comparison lacked power because of the limited amount of data available for analysis. CONCLUSIONS: More women are dissatisfied after endometrial destruction than after hysterectomy. Dissatisfaction rates are low after all treatments, and hysterectomy is associated with increased length of stay in hospital and a longer recovery period. Definitive evidence on effectiveness of Mirena compared with more invasive procedures is lacking.

Outpatient microwave endometrial ablation: 5-year follow-up of a randomised controlled trial without endometrial preparation versus standard day surgery with endometrial preparation.

The objective was to compare long-term outcomes following outpatient microwave endometrial ablation in the postmenstrual phase with those following day surgery microwave endometrial ablation after standard drug-based endometrial preparation. Of the women originally recruited, 154/197 (78%) returned questionnaires. The primary outcome of satisfaction was high in both groups (71% postmenses versus 65% preparation) as were the amenorrhoea rates (84% versus 87%). There was no significant difference in the hysterectomy rates between the two arms. It can be concluded that microwave endometrial ablation outcomes are not affected in the long term by undertaking the procedure in the postmenstrual phase in an outpatient setting.

A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium: follow up at a minimum of 10 years.

OBJECTIVE: To compare outcomes and further operations at a minimum of 10 years following microwave endometrial ablation (MEA) or transcervical resection of the endometrium (TCRE). DESIGN: Follow up of a randomised controlled trial using postal questionnaires and operative databank review. SETTING: Gynaecology department of a large UK teaching hospital. MAIN OUTCOME MEASURES: Women's satisfaction with treatment, menstrual symptoms, changes in health-related quality of life, and additional treatments received. RESULTS: One-hundred and eighty-nine of the original 263 women returned questionnaires (72%) after a minimum of 10 years post-treatment. Those totally or generally satisfied with treatment numbered 77/129 (60%) in the microwave arm and 70/134 (52%) in the resection arm, the difference is not statistically significant. Bleeding and pain scores were highly significantly reduced and similar following both MEA and TCRE, achieving amenorrhoea rates of 83 and 88% respectively. The hysterectomy rate after 10 years was significantly different with 22 (17%) in the MEA and 38 (28%) in the TCRE arm (95% CI: -0.21, -0.13). CONCLUSIONS: Both techniques achieve significant and comparable improvements in menstrual symptoms, health-related quality of life and high rates of satisfaction. With the known operative advantages, lower costs and fewer hysterectomies, it is clear that MEA is a more effective and efficient treatment for heavy menstrual loss than TCRE.

Clinical outcomes from a randomised comparison of Microwave Endometrial Ablation with Thermal Balloon endometrial ablation for the treatment of heavy menstrual bleeding.

OBJECTIVE: To compare the clinical outcomes of microwave endometrial ablation and thermal balloon ablation for the treatment of heavy menstrual bleeding. DESIGN: A double blind randomised controlled trial. SETTING: A UK teaching hospital. POPULATION: Three hundred and twenty women requesting endometrial ablation. METHODS: Operative data collection and patient completed postal questionnaires were used to ascertain women's satisfaction with outcome, acceptability of each procedure, changes in menstrual symptoms and health related quality of life and additional treatments received. MAIN OUTCOME MEASURES: Primary outcomes were satisfaction and menstrual scores 1 year. Secondary outcomes were operative differences, acceptability of treatment and changes in health related quality of life. RESULTS: Both technologies achieved high levels of satisfaction (-1%, 95% CI (-11, 9)). Menstrual scores were also similar (4%, 95% CI (-7, 19)) Microwave had a significantly shorter operating time, reduced usage of antiemetics and opiate analgesia, increased discharge by 6 hours and fewer device failures. CONCLUSIONS: Both treatments are acceptable to women, with high levels of satisfaction. Microwave is quicker to perform with faster hospital discharge.

A randomised trial comparing local versus general anaesthesia for microwave endometrial ablation.

OBJECTIVE: To compare the acceptability of microwave endometrial ablation using a local anaesthesia/sedation regime or general anaesthesia. To compare recovery following treatment with each type of anaesthetic. DESIGN: Prospective randomised controlled trial with follow up of women who declined randomisation. SETTING: The gynaecology department of a large teaching hospital in the UK. POPULATION: All women referred for microwave endometrial ablation at the Aberdeen Royal Infirmary between July 1999 and September 2000 without a medical reason to favour one or other type of anaesthetic. METHODS: 191 women were equally randomised to undergo microwave endometrial ablation under general or local anaesthesia. Details were also collected for women not randomised because of an anaesthetic preference. All procedures were undertaken in an operating theatre. MAIN OUTCOME MEASURES: Data collected by questionnaire including the woman's view of treatment acceptability, operative details and post-operative recovery. RESULTS: Sixty-nine percent of eligible women would consider treatment under local anaesthesia. Ninety-one percent of microwave endometrial ablation procedures that started under local anaesthesia were completed without conversion to general anaesthesia. Anaesthetic type and allocation by randomisation or preference made no significant difference to the proportion of women describing treatment as totally or generally acceptable at two weeks. Neither parity nor cavity size predicted acceptability. Women allocated general anaesthesia were more likely to describe the procedure as totally acceptable and to choose the same anaesthetic again. There was no significant difference between anaesthetic groups regarding post-operative pain, nausea or recovery time. CONCLUSIONS: Microwave endometrial ablation under local anaesthesia was acceptable to the majority of women referred for treatment. There was no recovery advantage from local anaesthesia and almost 1 in 10 women who starting treatment under local anaesthesia needed a general anaesthetic because of discomfort. The incidence of post-operative pain and nausea means that treatment with this local anaesthetic/sedation regime remains a day case rather than an outpatient procedure.

Five-year follow up of women randomised to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes.

OBJECTIVE: To assess clinical status, changes in health related quality of life, and subsequent management five years after medical management or transcervical resection of the endometrium for treatment of heavy menstrual loss. DESIGN: Five year follow up using postal questionnaires and operative databank review. SETTING: Gynaecology department of a large UK teaching hospital. POPULATION: Women referred to the gynaecologist for treatment of heavy menstrual loss. METHODS: Eligible women, without a treatment preference, were randomised equally to either medical treatment or transcervical resection of the endometrium. MAIN OUTCOME MEASURES: Women's satisfaction with treatment, menstrual status, changes in health related quality of life, and additional treatments received at five years. RESULTS: One hundred and forty-four patients completed questionnaires, achieving 77% follow up (medical n = 71/94; transcervical resection of the endometrium n = 73/93). At five-year follow up, 7/71 (10%) of those randomised to the medical arm still used medical treatment, while 72/94 (77%) had undergone surgical treatment and 17/94 (18%) a hysterectomy. Twenty-five (27%) women allocated to transcervical resection of the endometrium had undergone further surgery, 18/93 (19%) a hysterectomy. At five years women initially randomised to medical treatment were significantly less likely to be totally satisfied (P < 0.01, difference 21%, 95% CI -37% to -4%), or to recommend their allocated treatment to a friend (P < 0.001, difference 59%, 95% CI -73% to -45%). Bleeding and pain scores were similar in both groups and highly significantly reduced. Significantly more women in the transcervical resection of the endometrium arm had no bleeding or very light bleeding (P < 0.02, difference -22%, CI -31% to -4%), and they had significantly less days heavy bleeding (P < 0.02). Short Form 36 health survey scores were significantly improved from baseline for all eight health scales in the transcervical resection of the endometrium arm, and four in the medical arm. CONCLUSIONS: A policy of immediate transcervical resection of the endometrium for women referred to a gynaecologist for treatment of heavy menstrual loss achieves higher levels of satisfaction, better menstrual status, and greater improvements in health related quality of life than medical treatment. In addition, transcervical resection of the endometrium is safe and does not lead to an increase in the number of hysterectomies. An effective endometrial ablative technique should be offered to all eligible women seeking treatment of their heavy menses from a gynaecologist.

Comparison of microwave endometrial ablation and transcervical resection of the endometrium for treatment of heavy menstrual loss: a randomised trial.

BACKGROUND: Various new endometrial ablation techniques have emerged for the treatment of menorrhagia. We undertook a randomised controlled trial comparing one new technique, microwave endometrial ablation (MEA), with a proven procedure, transcervical resection of the endometrium (TCRE), for women with heavy menstrual loss. METHODS: 263 eligible and consenting women, referred for endometrial ablative surgery, were randomly assigned MEA (Microsulis plc, Waterlooville, Hampshire, UK; n=129) or TCRE (n=134). 230 participants were needed to give 80% power of demonstrating a 15% difference in satisfaction with treatment. All procedures were done under general anaesthesia 5 weeks after endometrial thinning with goserelin 3.6 mg. Questionnaires were completed at recruitment and at 12 months' follow-up. The primary outcome measures were patients' satisfaction with and the acceptability of treatment. Analysis was by intention to treat among women followed up to 12 months (n=116 MEA, n=124 TCRE). FINDINGS: At 12 months, 89 (77%) women in the MEA group and 93 (75%) in the TCRE group were totally or generally satisfied with their treatment (95% CI for difference -12 to 17) and 109 (94%) versus 112 (90%) found it acceptable (-11 to 35). Mean operating times were shorter for MEA than for TCRE (11.4 vs 15.0 min, p=0.001) and the postoperative stay slightly but not significantly shorter. One blunt perforation occurred in each study group resulting in one immediate hysterectomy (TCRE group). Of eight health-related quality of life dimensions, all were improved after MEA (six significantly) and seven were improved after TCRE (all significantly). INTERPRETATION: Both techniques achieved high rates of satisfaction and acceptability and both improved quality of life after 1 year. However, we cannot exclude a difference in satisfaction between the groups of less than 15%. MEA seems a suitable alternative to TCRE.

Two-year follow up of women randomised to medical management or transcervical resection of the endometrium for heavy menstrual loss: clinical and quality of life outcomes.

OBJECTIVE: To assess clinical status and changes in health related quality of life after two years in women randomised to medical management or transcervical resection of the endometrium (TCRE) for treatment of heavy menstrual loss. DESIGN: Two-year follow up using postal questionnaires and operative databank review. SETTING: Gynaecology department of a large UK teaching hospital. PARTICIPANTS: Women who had joined a randomised comparison of medical treatment with TCRE for heavy menstrual loss two years previously. MAIN OUTCOME MEASURES: Women's satisfaction with treatment, gynaecological symptoms, changes in health related quality of life, and additional treatments received at two years. RESULTS: Women allocated medical treatment were significantly less likely to be totally or generally satisfied (57% vs 79%, difference -22%, 95% CI -36, -9%), to find their management acceptable (77% vs 93%, difference -16%, 95% CI -26, -4%), or to recommend their allocated treatment (24% vs 78%, difference -54%, 95% CI -61, -33%). In the medical cohort 59% of women had undergone TCRE, hysterectomy or both, whereas 17% in the TCRE cohort had undergone further surgery. Bleeding and pain scores were similar in the groups and highly significantly better than at recruitment. Short Form-36 health survey scores were significantly improved from baseline for five of the eight health scores in the medical arm, and seven in the TCRE arm. CONCLUSIONS: The results at two years consolidate the findings and conclusions based on the four-month follow up data. A policy of early TCRE is effective and safe and does not result in an increase in hysterectomies. It should not be routinely withheld in an effort to try alternative medical therapies.