Stage II endometrial cancer: The diagnostic power of hysteroscopic excisional biopsy and MRI in the pre-operative cervical stroma assessment.

INTRODUCTION/BACKGROUND: Stage II Endometrial cancer (EC) accounts only for 12% of cases. Recent evidences redraw the weight of radicality in this stage as it would seem to have no impact on survival outcomes claiming for radicality when free surgical margins are not ensured to be achieved by simple hysterectomy. Thus, an accurate pre-operative evaluation might be crucial. This study aims to estimate the diagnostic power of Hysteroscopic excisional biopsy (HEB) of cervical stroma alone and combined with Magnetic resonance imaging (MRI) to predict the stage and concealed parametrial invasion in patients with preoperative stage II EC. METHODOLOGY: From January 2019 to November 2023, all patients evaluated at the Department of Gynaecology Oncology of Humanitas, Istituto Clinico Catanese, Catania, Italy, with a diagnosis of EC and evidence of cervical stromal diffusion on preoperative MRI and/or office hysteroscopy evaluation, considered suitable for laparoscopic modified type B hysterectomy, were consecutively included in the study. These underwent endometrial and cervical hysteroscopy excisional biopsy (HEB) for histological evaluation before definitive surgery. The data obtained were compared with the definitive histological examination (reference standard). RESULTS: Sixteen patients met the including/excluding criteria and were considered into the study. Stage II endometrial cancer were confirmed in 3 cases (18.7%). We reported 2 (12,5%) parametrial involvement (IIIB), 4 (25%) cases of lymph nodes metastasis (IIIc), 7 (43,7%) cases of I stage. MRI had a sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy (95% CIs) of 71%, 44%, 50%, 66% and 56.2 % respectively. HEB showed sensitivity, specificity, PPV, NPV and accuracy (95 % CI) of 85 %, 89 %, 85 %, 88 % and 87 % respectively. Comparing HEB + MRI to HEB alone, no statistical differences were noted in all fields. Considering parametrial invasion, MRI had better sensitivity but there were no statistical differences to HEB in other fields, showing both a worthy NPV. CONCLUSION: HEB was accurate in all fields for cervical stroma assessment and had a fine NPV to exclude massive cervical involvement up to parametrial. Considering the new FIGO staging a preoperative molecular and histological evaluation of the cervical stroma may be useful. Operative hysteroscopy seems to be a feasible and accurate method for this purpose.

Histological assessment of endometrial polyps resected by hysteroscopy.

OBJECTIVE: This study aimed to analyze the clinical data and pathologic aspects of endometrial polyps (EMPs) excised completely during surgical hysteroscopy and assess the connection between premalignant and malignant EMPs. PATIENTS AND METHODS: This retrospective study includes 489 participants who underwent hysteroscopy due to endometrial polyps, and the clinical features and histological findings of the resected polyps analyzed. RESULTS: Participants with EMPs were divided into six groups according to histologic findings. The histologic finding of most cases was simple benign endometrial polyp [397 patients (81.2%)]. Malignant polyp was detected in 3 patients (0.6%). The histologic findings according to age, menopausal status, and menstrual bleeding patterns at the time of presentation to the outpatient clinic were compared; however, no significant difference was observed. 237 patients were observed to have menometrorrhagia, which was the most prevalent symptom reported. The distribution of polyp sizes observed at hysteroscopy according to histologic findings was compared, but no significant difference was observed. CONCLUSIONS: EMPs are often benign but can include premalignant or malignant tissue changes. Hysteroscopy is used for direct observation of the uterine cervix and resection of existing polyps, considering the increasing frequency of its use as a diagnostic and treatment tool.

Randomised controlled trials evaluating endometrial scratching: assessment of methodological issues.

STUDY QUESTION: Do randomised controlled trials (RCTs) evaluating endometrial scratching suffer from methodological issues including insufficient trial registration, statistical errors or irreproducibility, randomisation errors or miscellaneous issues? SUMMARY ANSWER: The majority of RCTs investigating endometrial scratching have methodological issues. WHAT IS KNOWN ALREADY: A large number of small RCTs investigating the effectiveness of endometrial scratching prior to in vitro fertilisation (IVF) and intrauterine insemination (IUI)/intercourse have reported favourable findings. Subsequently, systematic reviews incorporating these RCTs yielded meta-analyses in favour of endometrial scratching. Endometrial scratching has been widely adopted by infertility specialists around the world. Recently, an international RCT including 1364 women reported no benefit from endometrial scratching before IVF. STUDY DESIGN, SIZE, DURATION: We evaluated several methodological issues of RCTs investigating the effectiveness of endometrial scratching prior to IVF and IUI/intercourse. We identified 25 RCTs for IVF and 12 RCTs for IUI/intercourse with full-text publication. PARTICIPANTS/MATERIALS, SETTING, METHODS: We assessed the RCTs on the following criteria: adequacy of trial registration, statistical issues (description of statistical methods and reproducibility of univariable statistical analysis), excessive similarity or difference in baseline characteristics that is not compatible with chance (Monte Carlo simulations and Kolmogorov-Smirnov test) and miscellaneous methodological issues. MAIN RESULTS AND THE ROLE OF CHANCE: Of 25 RCTs evaluating endometrial scratching prior to IVF, only eight (32%) had adequate trial registration. In total, 10 (40%) RCTs had issues regarding statistical methods. Nine (69%, 13 applicable) RCTs had at least one inconsistency between reported and reproduced univariable statistical analysis for categorical baseline/intermediate characteristics. Statistical results of at least one outcome were not reproducible in 14 (74%, 19 applicable) RCTs. Only two (8%) RCTs had none of the above issues. Suggested by the simulations, these RCTs did not significantly violate the null hypothesis that the baseline characteristics were the results of a properly conducted randomisation process (P = 0.4395).Of 12 IUI/intercourse RCTs, only 2 (17%) had adequate trial registration. In total, five (42%) studies had issues of statistical methods. Inconsistency between reported and reproduced univariable analysis for baseline/intermediate categorical variable(s) was found in four (57%, 7 applicable) RCTs. Statistical analysis was not reproducible for at least one outcome in eight (80%, 10 applicable) studies. All RCTs had at least one of the above issues. These RCTs were inconsistent with the null hypothesis that their baseline characteristics were the results of proper randomised allocation (P = 1.659*10-7). LIMITATIONS, REASONS FOR CAUTION: We were unable to assess RCTs which were not published as full-text papers. We could not analyse individual participant data to investigate possible reasons for statistical inconsistencies. The method to infer the likelihood of proper random sampling rests on assumptions including independent baseline characteristics, simple randomisation and no publication bias. WIDER IMPLICATIONS OF THE FINDINGS: The methodological issues common to RCTs evaluating endometrial scratching may have biased the results of the trials. Further development and validation of these novel methods may be helpful for the critical appraisal of RCTs. STUDY FUNDING/COMPETING INTEREST(S): No external funding was sought to support this work. B.W.M. is supported by a National Health Medical Research Council (NHMRC) Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck and Guerbet. D.W. is supported by a grant from the Paracelsus Medical University Salzburg, Austria (PMU Research Fund-PMU FFF Number: L-18/02/006-WET) and by Drs Haackert Foundation, Germany. S.L. is an author of a trial included in this study, an author of an included systematic review and a Cochrane editor. All other authors have no conflicts of interest. TRIAL REGISTRATION NUMBER: N/A.

Use and Misuse of Opioids After Gynecologic Surgical Procedures.

OBJECTIVE: To examine the rate of opioid use for gynecologic surgical procedures and to investigate persistent opioid use among those women who received an initial opioid prescription. METHODS: A retrospective cohort study using the MarketScan database was performed. MarketScan is a claims-based data source that captures claims from more than 50 million privately insured patients and 6 million Medicaid enrollees from 12 states. We identified women who underwent major and minor gynecologic surgery from 2009 to 2016. Among women who received an opioid prescription, new persistent opioid use was defined as receipt of one or more opioid prescriptions from 90 to 180 days after surgery with no intervening additional procedures or anesthesia. Multivariable models were used to examine associations between clinical characteristics and any use and new persistent use of opioids. RESULTS: A total of 729,625 patients were identified. Overall, 60.0% of patients received a perioperative opioid prescription. Receipt of an opioid prescription ranged from 36.7% in those who underwent dilation and curettage to 79.5% of patients who underwent minimally invasive hysterectomy. Among patients who received a perioperative opioid prescription, the rate of new persistent opioid use overall was 6.8%. The rate of new persistent opioid use was 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7.0% for tubal ligation, and 7.2% for dilation and curettage (P<.001). In a multivariable model, patients who underwent dilation and curettage and endometrial ablation were at highest risk for new persistent opioid use. Younger patients, Medicaid recipients, and patients with depression, anxiety, and substance use disorder more commonly had new persistent opioid use (P<.001 for all). Among women who received an opioid prescription, the rate of new persistent opioid use decreased over time from 7.0% in 2010 to 5.5% in 2016 (P<.001). CONCLUSION: The rate of new persistent opioid use after major and minor gynecologic procedures is substantial.

Comparison of Different Scoring Systems in the Assessment of Estrogen Receptor Status for Predicting Prognosis in Endometrial Cancer.

The objective of this article is to compare the effectiveness of various estrogen receptor (ER) scoring systems for predicting prognosis in endometrial cancer (EC). We retrospectively analyzed 195 cases of primary EC with complete follow-up information. Three different methods-the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criterion, histochemistry score (H-score), and Allred scoring system-were used to assess the degree of staining, and comparisons were made to determine which method correlated best with clinical outcomes. The ASCO/CAP criterion, H-score (cutoff value, 51-300), and Allred (cutoff value, 4-8) scoring systems showed high concordance in the following aspects: the ER status was significantly associated with subtype (type I vs. type II EC), newly recommended histologic type (grade 1-2, type I vs. grade 3, type I+type II EC), progesterone receptor status, overall survival, and cancer-specific survival in EC patients. Considering International Federation of Gynecology and Obstetrics stage, lymphovascular space invasion, and lymph node metastasis, the ASCO/CAP criterion significantly exceeded the other 2 scoring systems. Furthermore, cases judged as ER positive by the ASCO/CAP criterion, but ER negative by the other 2 scoring systems, displayed similarly favorable outcomes to those cases that were consistently admitted as ER positive by all 3 scoring systems. The ASCO/CAP criterion was superior to both H-score and Allred score in terms of predictive and prognostic values. This easy, simple, and highly efficient criterion should be recommended for routine assessment of ER in EC patients.

Effectiveness of Hysteroscopic Techniques for Endometrial Polyp Removal: The Italian Multicenter Trial.

STUDY OBJECTIVE: To compare the effectiveness and safety of different techniques of hysteroscopic polypectomy. DESIGN: Multicenter, prospective observational trial (Canadian Task Force classification II-2). SETTING: Nineteen Italian gynecologic departments (university-affiliated or public hospitals). PATIENTS: Consecutive patients suffering from endometrial polyps (EPs). INTERVENTIONS: Hysteroscopic polypectomy, as performed through different techniques. MEASUREMENTS AND MAIN RESULTS: Included in the study were 1404 patients (with 1825 EPs). The setting was an ambulatory care unit in 40.38% of the cases (567 women), of whom 97.7% (554) did not require analgesia/anesthesia. In the remaining 59.62% of women (837 women), the procedures were performed in an operating room under mild sedation, local or general anesthesia. Minor complications occurred in 32 patients (2.27%), without significant differences between the techniques used (p = ns). Uterine perforation occurred in 14 cases, all performed in the operating room with some kind of anesthesia, only 1 with a vaginoscopic technique and the remaining during blind dilatation (odds ratio [OR], 19.98; 95% confidence interval [CI], 1.19-335.79; p = .04). An incomplete removal of EPs was documented in 39 patients. Logistic regression analysis showed that a higher risk of residual EPs was associated with the use of a fiber-based 3.5-mm hysteroscope (OR, 6.78; 95% CI, 2.97-15.52; p <.001), the outpatient setting (OR, 2.17; 95% CI, 1.14-4.14; p = .019), and EPs located at the tubal corner (OR, 1.98; 95% CI, 1.03-2.79; p = .039). No association between incomplete EP removal and EP size or number was recorded (p = ns), as well as with the other variables evaluated. CONCLUSION: Outpatient polypectomy was associated with a minimal but significantly higher risk of residual EPs in comparison with inpatient polypectomy. Conversely, inpatient polypectomy was associated with a considerably higher risk of uterine perforation and penetration in comparison with office hysteroscopy. Because of lower intraoperative risks and higher cost-effectiveness, office hysteroscopy may be considered, whenever possible, as the gold standard technique for removing EPs.

Does endometrial scratching increase the rate of spontaneous conception in couples with unexplained infertility and a good prognosis (Hunault > 30%)? Study protocol of the SCRaTCH-OFO trial: a randomized controlled trial.

BACKGROUND: In the Netherlands, couples with unexplained infertility and a good prognosis to conceive spontaneously (i.e. Hunault > 30%) are advised to perform timed intercourse for at least another 6 months. If couples fail to conceive within this period, they will usually start assisted reproductive technology (ART). However, treatment of unexplained infertility by ART is empirical and can involve significant burdens. Intentional endometrial injury, also called 'endometrial scratching', has been proposed to positively affect the chance of embryo implantation in patients undergoing in vitro fertilization (IVF). It might also be beneficial for couples with unexplained infertility as defective endometrial receptivity may play a role in these women. The primary aim of this study is to determine whether endometrial scratching increases live birth rates in women with unexplained infertility. METHOD: A multicentre randomized controlled trial will be conducted in Dutch academic and non-academic hospitals starting from November 2017. A total of 792 women with unexplained infertility and a good prognosis for spontaneous conception < 12 months (Hunault > 30%) will be included, of whom half will undergo endometrial scratching in the luteal phase of the natural cycle. The women in the control group will not undergo endometrial scratching. According to Dutch guidelines, both groups will subsequently perform timed intercourse for at least 6 months. The primary endpoint is cumulative live birth rate. Secondary endpoints are clinical and ongoing pregnancy rate; miscarriage rate; biochemical pregnancy loss; multiple pregnancy rate; time to pregnancy; progression to intrauterine insemination (IUI) or IVF; pregnancy complications; complications of endometrial scratching; costs and endometrial tissue parameters associated with reproductive success or failure. The follow-up duration is 12 months. DISCUSSION: Several small studies show a possible beneficial effect of endometrial scratching in women with unexplained infertility trying to conceive naturally or through IUI. However, the quality of this evidence is very low, making it unclear whether these women will truly benefit from this procedure. The SCRaTCH-OFO trial aims to investigate the effect of endometrial scratching on live birth rate in women with unexplained infertility and a good prognosis for spontaneous conception < 12 months. TRIAL REGISTRATION: NTR6687 , registered August 31st, 2017. PROTOCOL VERSION: Version 2.6, November 14th, 2018.

Multiplex PCR from Menstrual Blood: A Non-Invasive Cost-Effective Approach to Reduce Diagnostic Dilemma for Genital Tuberculosis.

AIM: Genital tuberculosis (GTB) is a potent contributor to irreversible damage to the reproductive system and infertility in females. As no gold standard diagnostic tool is yet available, clinical suspicion and relatively insensitive approaches such as histopathology, laparoscopy and hysterosalpingogram are currently critical determinants in the diagnosis of GTB. Although a polymerase chain reaction (PCR)-based assay using endometrial tissue seems promising, sampling does require an invasive procedure. OBJECTIVE: We hypothesized that menstrual blood may provide an alternate non-invasive source of samples for PCR-based GTB diagnosis. METHODS: We enrolled 195 women with primary infertility in whom GTB was suspected. We obtained ethics committee approval from our institution and written informed consent from subjects. Endometrial tissue and menstrual blood was collected from the subjects and culture, histopathology, and multiplex PCR with both sample type was performed for each subject. RESULTS: The sensitivity and specificity of multiplex PCR was, respectively, 90.2 and 86.1% for menstrual blood, 95.8 and 84.3% for endometrial tissue, and 64.8 and 93.2% for histopathology staining. CONCLUSIONS: A strong clinical suspicion aided with multiplex PCR using menstrual blood may significantly reduce the diagnostic dilemma for GTB diagnosis in a non-invasive, sensitive, rapid, and cost-effective manner.

Hysteroscopic Endometrial Polypectomy: Clinical and Economic Data in Decision Making.

STUDY OBJECTIVE: To compare the costs of hysteroscopic polypectomy using mechanical and electrosurgical systems in the hospital operating room and an office-based setting. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Tertiary referral hospital and center for gynecologic care. PATIENTS: Seven hundred and fifty-four women who underwent endometrial polypectomy between January 20, 2015, and April 27, 2016. INTERVENTIONS: Hysteroscopic endometrial polypectomy performed in the same-day hospital setting or office setting using one of the following: bipolar electrode, loop electrode, mechanical device, or hysteroscopic tissue removal system. MEASUREMENTS AND MAIN RESULTS: The various costs associated with the 2 clinical settings at Palagi Hospital, Florence, Italy were compiled, and a direct cost comparison was made using an activity-based cost-management system. The costs for using reusable loop electrode resection-16 or loop electrode resection-26 were significantly less expensive than using disposable loop electrode resection-27, the tissue removal system, or bipolar electrode resection (p = .0002). Total hospital costs for polypectomy with all systems were significantly less expensive in an office setting compared with same-day surgery in the hospital setting (p = .0001). Office-based hysteroscopic tissue removal was associated with shorter operative time compared with the other procedures (p = .0002) CONCLUSION: The total cost of hysteroscopic polypectomy is markedly higher when using disposable equipment compared with reusable equipment, both in the hospital operating room and the office setting. Same-day hospital or office-based surgery with reusable loop electrode resection is the most cost-effective approach in each settings, but requires experienced surgeons. Finally, the shorter surgical time should be taken into consideration for patients undergoing vaginal polypectomy in the office setting, owing more to patient comfort than to cost savings.

Endometrial resection and global ablation in the normal uterus.

There are various methods that can be used to destroy the endometrium as a treatment for menorrhagia. This chapter reviews the history, rationale, evidence, indications and long-term safety and efficacy of the current techniques. It also discusses endometrial ablation in the context of its clinical utility in comparison with existing alternative treatments.

Disparities in Surgical Care Among Women With Endometrial Cancer.

OBJECTIVE: To analyze contemporary U.S. use of minimally invasive surgery for the treatment of endometrial cancer and associated inpatient complications and costs. METHODS: In this retrospective cohort study, the National Inpatient Sample database was analyzed in patients with nonmetastatic endometrial cancer who underwent hysterectomy during 2012-2013. Hierarchical multiple logistic regression and propensity score matching were used to compare complications among patients treated with open compared with minimally invasive hysterectomy surgery. Cost of care was also compared using generalized linear modeling. RESULTS: We identified 9,799 patients; 52.4% underwent open and 47.6% minimally invasive hysterectomy. Many patients (43.4%) were treated at low-volume hospitals (less than 10 endometrial cancer cases annually). Patients were less likely to undergo open surgery in high-volume compared with low-volume hospitals (51.8% compared with 58.1%, respectively; adjusted odds ratio [OR] 0.35, 95% confidence interval [CI] 0.13-0.94) and more likely to undergo open surgery in rural compared with urban teaching hospitals (75.6% compared with 51.1%, respectively; adjusted OR 14.34, 95% CI 9.66-21.27), government compared with nonprofit hospitals (61.3% compared with 51.1%, respectively; adjusted OR 1.66, 95% CI 1.15-2.39), and in patients of black (67.9%; OR 1.46, 95% CI 1.30-1.65) and "other" race (60.5%; adjusted OR 2.39, 95% CI 1.99-2.87) compared with white race (49.2%, referent). Open surgery was associated with increased perioperative complications (adjusted OR 2.80, 95% CI 2.48-3.17) and a $1,243 increase in cost per case compared with minimally invasive approaches (P<.001). Using minimally invasive surgery for 80% of study patients may have averted 2,733 complications and saved approximately $19 million. CONCLUSION: Most U.S. women with endometrial cancer continue to be treated with open hysterectomy surgery despite increased complication rates and financial costs associated with this approach. A disparity in endometrial cancer surgical care exists that is affected by patient race and hospital geography and cancer volumes.

Global ablation techniques.

Global endometrial ablation techniques are a relatively new surgical technology for the treatment of heavy menstrual bleeding that can now be used even in an outpatient clinic setting. A comparison of global ablation versus earlier ablation technologies notes no significant differences in success rates and some improvement in patient satisfaction. The advantages of the newer global endometrial ablation systems include less operative time, improved recovery time, and decreased anesthetic risk. Ablation procedures performed in an outpatient surgical or clinic setting provide advantages both of potential cost savings for patients and the health care system and improved patient convenience.

A cost-utility analysis of microwave endometrial ablation versus thermal balloon endometrial ablation.

OBJECTIVE: To evaluate the cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBALL) for heavy menstrual bleeding. METHODS: A cost-utility analysis performed alongside a pragmatic RCT in a single hospital within Scotland on women undergoing MEA and TBALL. Resource use data collected from all 314 trial participants were combined with study specific and published unit cost data to estimate a cost per patient. Quality-adjusted life-years (QALYs) were based on EQ-5D responses at baseline, 2 weeks, 6 and 12 months. The incremental cost per QALY of TBALL versus MEA was calculated and bootstrapping was performed to determine the likelihood that a treatment would be cost-effective at different threshold values for society's willingness to pay for a QALY. RESULTS: The mean cost of TBALL (10 years equipment life, 100 uses annually) of reusable equipment was pound181 (95% confidence interval [CI] pound70-434) greater than MEA. There were no statistically significant differences between the total nonhealth costs and health benefits of the two arms. On average, MEA provided more QALYs after adjusting for baseline EQ-5D score (0.017; 95% CI 0.017-0.051). In terms of mean incremental cost per QALY, MEA was, on average, dominant (less costly and at least as effective) and there was over a 90% chance that MEA would be considered cost-effective at a pound20,000 threshold of a cost per QALY. CONCLUSIONS: MEA is likely to be more cost-effective than TBALL at 1 year. Further longer-term follow-up is, however, needed.

Feasibility of endometrial assessment after thermal ablation.

OBJECTIVE: To evaluate the feasibility of endometrial assessment after endometrial thermal ablation. STUDY DESIGN: Prospective observational study. A total of 57 women (age 47-52 years), who had undergone endometrial thermal ablation as a treatment for heavy menstrual bleeding (HMB) 3-10 years (mean 6 years) earlier, were examined with transvaginal ultrasound and saline sonohysterography. Endometrial samples were collected with a Pipelle device. Visualisation of endometrium, access to uterine cavity, change in cavity length, success in outpatient endometrial sampling and success in sonohysterography were evaluated. RESULTS: Endometrial thickness was 4.5mm in amenorrhoeic women (n=17), 5.6mm in eumenorrhoeic women (n=37) and 6.6mm in hypermenorrhoeic women (n=3). An endometrial sample was successfully taken in 44 (77%) women, and in 13 (23%) women endometrial sample taking failed. The length of the uterine cavity compared to the length measured before endometrial thermal ablation was 0.5-5 cm (mean 2 cm) shorter in 34 women, unchanged in four women and longer in five women. The uterine cavity distended regularly in only nine (16%) women. In 14 (25%) women the cavity distended irregularly or only partly, and in 24 (42%) women the uterine cavity did not distend at all, but appeared as a narrow tube. In 10 (18%) women the sonohysterography catheter did not enter the uterine cavity at all. CONCLUSION: Endometrial assessment is compromised after previous endometrial thermal ablation. Both endometrial sampling and sonohysterography fail quite often, causing problems in diagnosis of abnormal bleeding. Intrauterine adhesions may also decrease the reliability of the endometrial sampling.

Cost-utility of levonorgestrel intrauterine system compared with hysterectomy and second generation endometrial ablative techniques in managing patients with menorrhagia in the UK.

OBJECTIVE: To estimate the cost-utility of levonorgestrel intrauterine system (LNG-IUS; Mirena) compared to second generation endometrial ablative techniques [i.e. microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA)) and hysterectomy in the UK. METHODS: Clinical and utility data from a 5-year randomised controlled trial comparing LNG-IUS with hysterectomy were combined with further data from published studies to construct a state-transition (Markov) model. The model depicted the movement of patients between health states over 5 years following treatment for menorrhagia. The model was used to estimate the cost-utility of LNG-IUS followed by ablation (L-A); LNG-IUS followed by hysterectomy (L-H); immediate ablation (MEA or TBEA) and immediate hysterectomy in the UK at 2004/2005 prices, from the perspective of the UK's National Health Service (NHS). MAIN OUTCOME MEASURES AND RESULTS: The expected 5-yearly cost of treating menorrhagia with L-A, L-H, TBEA, MEA and hysterectomy was estimated to be 828 pounds sterling, 1355 pounds sterling, 1679 pounds sterling, 1812 pounds sterling and 2983 pounds sterling per patient respectively and the expected level of health gain to be 4.14, 4.12, 4.13, 4.13 and 4.01 QALYs per patient respectively. LNG-IUS followed by ablation dominated all the alternative treatments. Hysterectomy was dominated by the alternative treatments. Sensitivity analysis found the model to be sensitive to the quality of life data used. CONCLUSION: Within the model's limitations, LNGIUS followed by ablation appears to offer the NHS a cost-effective treatment for menorrhagia, when compared to immediate surgery, affording the NHS a less expensive treatment modality without detrimental effects on resulting health gain.

Managing drug-resistant essential menorrhagia without hysterectomy.

Menorrhagia is a common disorder that requires plenty of resources. Rapid developments in medical technology have resulted in new management strategies, which are true alternatives to hysterectomy. In many countries the levonorgestrel-releasing intrauterine system (LNG-IUS) and endometrial destruction techniques are available for menorrhagia. Clinicians must answer questions about cost, effectiveness and quality of medical care when choosing the treatment option. This review integrates the results from the latest studies and review articles about LNG-IUS and endometrial destruction techniques by addressing the key clinical issues in menorrhagia. Both LNG-IUS and endometrial ablation seem to be good and effective alternative options to hysterectomy. Although these treatments have relatively high failure rates, the majority of women are satisfied and the cost-effectiveness of these treatments are better than that of hysterectomy. Both treatments have their advantages and disadvantages. Thus far LNG-IUS seems to be more cost-effective than endometrial resection or hysterectomy at 5 years follow-up. However, second generation ablation techniques may offer better cost-effectiveness than the first generation techniques, but the evidence is insufficient.

A cost-utility analysis of hysterectomy, endometrial resection and ablation and medical therapy for menorrhagia.

BACKGROUND: Four types of treatment [hysterectomy, endometrial resection/ablation, levonorgestrel-releasing intrauterine system (LNG-IUS) and oral medical therapy] are available for management of menorrhagia. The objective of this study was to compare the cost and quality-adjusted life-years (QALYs) gained by these four treatment alternatives. METHODS: A Markov model was designed to simulate the healthcare resource utilization and QALYs of the four treatment alternatives for patients presenting with menorrhagia over 5 years. Clinical inputs were estimated from literature, and the cost analysis was conducted from the perspective of healthcare provider in Hong Kong. RESULTS: The base-case analysis showed that the hysterectomy group was the most effective (4.725 QALYs) alternative with the highest cost (USD6878, 1USD=7.8HKD). The incremental cost per additional QALY (ICER) gained by hysterectomy was USD23 500. The probability of extra surgery in the endometrial resection/ablation was an influential factor. Probabalistic sensitivity analysis of 10,000 simulations of the Monte Carlo model showed that the hysterectomy group gained higher number of QALYs than the LNG-IUS, oral medical treatment and endometrial resection/ablation groups, 99, 99 and 98% of the time, and it was more costly than the other three groups over 85% of the time. CONCLUSIONS: Hysterectomy appears to be cost effective, with ICER less than USD50,000, for management of menorrhagia.

An update on second-generation devices for endometrial ablation.

Menorrhagia is a very common problem. Hysterectomy has been the traditional surgical treatment of choice guaranteeing amenorrhoea. It is 100% effective but is associated with surgical complications, and is more costly in terms of economic impact and recovery time. Minimally invasive procedures to ablate the endometrium reduce complications and recovery time. The newer second-generation endometrial ablation devices negate the need for surgery under direct hysteroscopic vision, thus ensuring that the treatments are not operator dependent. However, they heavily rely on the device themselves to ensure safety and efficacy. There are a variety of these devices currently available on the market. The authors will review these devices and provide the evidence for their suitability in various settings.

A randomised controlled trial of microwave endometrial ablation without endometrial preparation in the outpatient setting: patient acceptability, treatment outcome and costs.

OBJECTIVE: To compare outpatient microwave endometrial ablation (MEA) in the postmenstrual phase to standard MEA treatment after drug preparation in a day case theatre environment. DESIGN: A randomised controlled trial. SETTING: A large United Kingdom teaching hospital. POPULATION: Two hundred and ten women complaining of excessive menstrual loss. METHODS: Two hundred and ten women with excessive menstrual loss were randomised. Ninety-seven women were treated as outpatients in the immediate post-menstrual phase and 100 were treated in an operating theatre after hormonal preparation. All procedures were commenced under local anaesthesia with or without conscious sedation. Analysis was by modified intention to treat. MAIN OUTCOME MEASURES: Primary outcome measures were satisfaction with treatment (measured at one year) and acceptability of treatment (measured at two weeks). Secondary outcome measures were menstrual outcome and financial cost. RESULTS: Significantly more women found treatment post-menses acceptable; 86 (89.5%) versus 76 (76.0%) [difference in proportions 13.6%, 95% CI (3.0%, 23.9%)]. Similar numbers in each arm were totally or generally satisfied with the treatment, 86 (92.5%) versus 84 (88.4%) [difference in proportions 4.1%, 95% CI (-4.7%, 12.9%)] while amenorrhoea rates at one year were comparable, 52 (55.9%) versus 60 (61.9%). [difference in proportions -5.9%, 95% CI (-19.8%, 7.6%)]. The mean health service costs were 124 pounds (95% CI 86-194 pounds) lower for the patients in the post-menses group. CONCLUSION: MEA performed under local anaesthesia (with or without conscious sedation) in the post-menstrual phase achieves high levels of satisfaction is very acceptable to patients and results in significantly reduced health service costs. Importantly menstrual outcomes are not affected by omission of drug preparation. There is now good evidence to support the use of MEA, without drug endometrial preparation, in the outpatient setting.

Experience with shared decision making in gynaecological practice: treatment decisions in patients with dysfunctional uterine blood loss.

OBJECTIVE: To study the impact of introducing a blood loss chart as a means to support treatment selection in women with dysfunctional uterine blood loss. STUDY DESIGN: Retrospective chart review, prospective observational study, and decision modelling. RESULTS: Introduction of a blood loss chart resulted in a 50% reduction of re-treatments within 1 year (from 25% to 12.5%). The use of the blood loss chart resulted in a slightly higher expected value and lower costs, which is reflected in a more favourable cost/quality adjusted life year (QALY) ratio. CONCLUSION: The use of a blood loss chart as an aid in treatment selection in women with dysfunctional uterine blood loss is feasible. Although its use requires an extra outpatient visit, the associated extra costs are off-set by its impact on initial treatment selection, and, in particular, on the probability of re-treatment within 1 year of follow-up.