Stuart A. Jack

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 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.

Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation

Objective  To compare patient satisfaction, discomfort, procedure time, success rate and adverse events of hysteroscopic (ESSURE, Conceptus Inc, San Carlos, USA) versus laparoscopic sterilisation.

Microwave Endometrial Ablation vs. Rollerball Electroablation for Menorrhagia: A Multicenter Randomized Trial

STUDY OBJECTIVE To compare the effectiveness, safety, and acceptability of microwave endometrial ablation (MEA) with those of rollerball electroablation (REA) for the treatment of menorrhagia. DESIGN Randomized clinical trial (Canadian Task Force classification I). SETTING Eight academic medical centers and private medical practices. PATIENTS Three hundred twenty-two women with documented menorrhagia due to benign causes. INTERVENTION MEA or REA. MEASUREMENTS AND MAIN RESULTS By intent-to-treat analysis, the success rate of MEA at 12 months (87.0%; CI 81.7%-91.2%) did not differ significantly (p = .40) from that of REA (83.2%; CI 74.7%-89.7%). Among evaluable patients, success rate was also similar (p = .24) in the MEA (96.4%; CI 92.7%-98.5%) and REA (92.7%; CI 85.6%-97%) groups. The amenorrhea rate in evaluable patients after MEA was 61.3% (CI 54.1 %-68.2%). In patients with myomas, the success and amenorrhea rates in evaluable patients after MEA were 90.3% (CI 74.2%-98%) and 61.3% (CI 42.2%-78.2%), respectively. In evaluable patients with body mass index of 30 kg/m2 or greater, MEA success rate was 96.7% (CI 88.5%-99.6%) compared with 81.8% (CI 59.7%-94.8%) for REA (p = .042). The ablation procedure was performed under IV sedation in 62% of patients in the MEA group versus 18% of patients in the REA group (p <.001); whereas, general anesthesia was employed more often in patients undergoing REA (37% vs. 76%, p <.001). No major complications were encountered. Patient satisfaction with results of treatment was high (98.5% of the MEA and 99.0% of the REA group). CONCLUSIONS Microwave endometrial ablation is an efficacious and safe procedure for the treatment of menorrhagia. Over half of patients treated with MEA achieve amenorrhea, and the procedure is suitable for women with myomas and irregular uterine cavities. The procedure is easily learned and can be performed rapidly, under IV sedation in most cases.

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.

Gabapentin for the Management of Chronic Pelvic Pain in Women (GaPP1) : A Pilot Randomised Controlled Trial

Chronic pelvic pain (CPP) affects 2.1–24% of women. Frequently, no underlying pathology is identified, and the pain is difficult to manage. Gabapentin is prescribed for CPP despite no robust evidence of efficacy. We performed a pilot trial in two UK centres to inform the planning of a future multicentre RCT to evaluate gabapentin in CPP management. Our primary objective was to determine levels of participant recruitment and retention. Secondary objectives included estimating potential effectiveness, acceptability to participants of trial methodology, and cost-effectiveness of gabapentin. Women with CPP and no obvious pelvic pathology were assigned to an increasing regimen of gabapentin (300-2700mg daily) or placebo. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to six months. The analyses by treatment group were by intention-to-treat. Interviews were conducted to evaluate women’s experiences of the trial. A probabilistic decision analytical model was used to estimate cost-effectiveness. Between September 2012–2013, 47 women (34% of those eligible) were randomised (22 to gabapentin, 25 to placebo), and 25 (53%) completed six-month follow-up. Participants on gabapentin had less pain (BPI difference 1.72 points, 95% CI:0.07–3.36), and an improvement in mood (HADS difference 4.35 points, 95% CI:1.97–6.73) at six months than those allocated placebo. The majority of participants described their trial experience favorably. At the UK threshold for willingness-to-pay, the probabilities of gabapentin or no treatment being cost-effective are similar. A pilot trial assessing gabapentin for CPP was feasible, but uncertainty remains, highlighting the need for a large definitive trial. Trial registration Controlled-Trials.com ISRCTN45178534

GaPP: a pilot randomised controlled trial of the efficacy of action of gabapentin for the management of chronic pelvic pain in women: study protocol

Introduction Chronic pelvic pain (CPP) affects >1 million UK women. Annual healthcare costs are estimated at >£150 million. Proven interventions for CPP are limited, and treatment is often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions, but there are insufficient data supporting value in CPP specifically. The mechanism by which gabapentin exerts its analgesic action is unknown. Given the prevalence and costs of CPP, the authors believe that a large, multicentre, placebo-controlled, double-blind randomised controlled trial to evaluate the efficacy of gabapentin in management of CPP is required. The focus of this study is a pilot to inform planning of a future randomised controlled trial. Methods and analysis The authors plan to perform a two-arm, parallel, randomised controlled pilot trial. The authors aim to recruit 60 women with CPP in NHS Lothian and NHS Grampian (UK) and randomise them to gabapentin or placebo. Response to treatment will be monitored by questionnaire compared at 0, 3 and 6 months. The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness and acceptability to participants of the proposed methods of recruitment, randomisation, drug treatments and assessment tools and to perform a pretrial cost-effectiveness assessment of treatment with gabapentin. Ethics and dissemination Ethical approval has been obtained from the Scotland A Research Ethics Committee (LREC 12/SS/0005). Data will be presented at international conferences and published in peer-reviewed journals. Trial registration number ISRCTN70960777.

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

Please cite this paper as: Sambrook A, Jack S, Cooper K. Outpatient microwave endometrial ablation: 5‐year follow‐up of a randomised controlled trial without endometrial preparation versus standard day surgery with endometrial preparation. BJOG 2010;117:493–496.

Acute hemoperitoneum 6 weeks post-laparoscopic salpingectomy—a rare case of secondary peritoneal trophoblast implantation

Secondary peritoneal trophoblast implantation with bleeding can be a problematic diagnosis if there has been previous definitive surgical management of ectopic pregnancy. Although more often seen after conservative surgical management with salpingostomy, there are a few reported cases following salpingectomy, for which there is often no formal follow-up. Diagnosis can be challenging as there are no agreed definitions for postoperative beta human chorionic gonadotropin (βhCG) levels and no specific clinical findings. However, persistent trophoblastic tissue should be considered as a cause in a patient re-presenting with nonspecific abdominal pain after surgical management of ectopic pregnancy. Here, we report a case where a healthy young patient presented with significant hemoperitoneum 16 days after an uncomplicated laparoscopic salpingectomy.