Objective To compare patient satisfaction, discomfort, procedure time, success rate and adverse events of hysteroscopic (ESSURE, Conceptus Inc, San Carlos, USA) versus laparoscopic sterilisation. Design Cohort controlled comparative study.Setting The day surgery and outpatient unit of three large UK hospitals.Population Eighty-nine women requesting sterilisation were enrolled into the study.Methods A 2:1 ratio of ESSURE placement to laparoscopic sterilisation was undertaken. Laparoscopic sterilisation was carried out under general anaesthesia in the day surgery unit whereas all ESSURE procedures were carried out in a dedicated outpatient facility. All patients completed a self-assessment diary on days 7 and 90 post-operatively. Patient satisfaction, tolerance and discomfort were measured using an ordinal Likert style scale. Data were analysed using the m 2 test for statistical significance. Main outcome measures The primary outcome measure is patient satisfaction with ESSURE versus laparoscopic sterilisation. This included satisfaction with the decision to proceed with the relevant sterilisation method, recovery from the procedure and overall satisfaction following either ESSURE or laparoscopic sterilisation. Secondary outcome measures include successful completion of procedure, procedure time, tolerance, patient discomfort and post-operative adverse events. Results All women who underwent laparoscopic sterilisation had the procedure successfully completed whereas the overall bilateral device placement rate for ESSURE was 81%. Patient satisfaction with their decision to undergo either ESSURE or laparoscopic sterilisation was high with 94% of the ESSURE group being 'very' or 'somewhat' satisfied at 90 days post-procedure versus 80% in the laparoscopic sterilisation group. At 90 days post-procedure 100% of women in the ESSURE group were 'very satisfied' with their speed of recovery versus 80% in the laparoscopic sterilisation group. The procedure time (defined from the time of insertion of the hysteroscope or laparoscope to its removal) took significantly longer for ESSURE than laparoscopic sterilisation (mean ¼ 13.2 vs 9.7 minutes, P ¼ 0.045). However, the time required for insertion of a Verres needle and insufflation of the abdominal cavity is a necessary part of the laparoscopic sterilisation and had it been included would bring the procedures times more in line with each other. The mean time spent in hospital was significantly shorter for the ESSURE group than the laparoscopic group (188.7 vs 396.1 minutes, P < 0.005). Eighty-two percent of women in the ESSURE group described their tolerance of the procedure between 'good and excellent' compared with only 41% of the laparoscopic sterilisation group (P ¼ 0.0002). Only 31% of the ESSURE group reported moderate or severe pain following the procedure compared with 63% of the laparoscopic sterilisation group (P ¼ 0.08). Only 11% of patients had problems immediately post-operatively in the ESSURE group compared with 27% in the laparoscopy group. Finally, in the mor...

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 registrationControlled-Trials.com ISRCTN45178534

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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 ¼ 71/94; transcervical resection of the endometrium n ¼ 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.

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 [difference in proportions À5.9%, 95% CI (À19.8%, 7.6%)]. The mean health service costs were £124 (95% CI £86-194) lower for the patients in the post-menses group. Conclusion MEA performed under local anaesthesia (with or without conscious sedation) in the postmenstrual 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.