Ray Garry

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy

Objective To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. Design Two parallel, multicentre, randomised trials. Setting 28 UK centres and two South African centres. Participants 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. Results In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. Conclusions Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.

Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials

Abstract Objective To evaluate the most appropriate surgical method of hysterectomy (abdominal, vaginal, or laparoscopic) for women with benign disease. Design Systematic review and meta-analysis. Data sources Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and Biological Abstracts. Selection of studies Only randomised controlled trials were selected; participants had to have benign gynaecological disease; interventions had to comprise at least one hysterectomy method compared with another; and trials had to report primary outcomes (time taken to return to normal activities, intraoperative visceral injury, and major long term complications) or secondary outcomes (operating time, other immediate complications of surgery, short term complications, and duration of hospital stay). Results 27 trials (total of 3643 participants) were included. Return to normal activities was quicker after vaginal than after abdominal hysterectomy (weighted mean difference 9.5 (95% confidence interval 6.4 to 12.6) days) and after laparoscopic than after abdominal hysterectomy (difference 13.6 (11.8 to 15.4) days), but was not significantly different for laparoscopic versus vaginal hysterectomy (difference −1.1 (−4.2 to 2.1) days). There were more urinary tract injuries with laparoscopic than with abdominal hysterectomy (odds ratio 2.61 (95% confidence interval 1.22 to 5.60)), but no other intraoperative visceral injuries showed a significant difference between surgical approaches. Data were notably absent for many important long term patient outcome measures, where the analyses were underpowered to detect important differences, or they were simply not reported in trials. Conclusions Significantly speedier return to normal activities and other improved secondary outcomes (shorter duration of hospital stay and fewer unspecified infections or febrile episodes) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy is preferable to abdominal hysterectomy, although it brings a higher chance of bladder or ureter injury.

The effect of endometriosis and its radical laparoscopic excision on quality of life indicators

Objective To assess the effect of endometriosis and radical laparoscopic excision on the quality of life of women with this condition.

Six hundred endometrial laser ablations

Objective To report the effectiveness and safety of endometrial laser ablation in the treatment of menorrhagia, as determined by detailed follow-up of 600 operations for at least 6 months. Methods Operative data from 600 endometrial laser ablations performed on 524 women were collected. Five hundred one (96%) of these women were followed with consultations and questionnaires. The mean duration of follow-up was 15 months (range 6–42). Results No major operative morbidity occurred. There were no cases of primary or secondary hemorrhage, uterine perforations with the operating instrument, or immediate laparotomy. A successful outcome was reported by 83.4% of patients. A second endometrial laser ablation was required in 14.3% of the women. success increased with increasing age and low fluid absorption. Cavity length, operation time, duration of follow-up, and whether it was a first or second procedure were not associated with any difference in the success rate, although the hysterectomy rate tended to rise with increasing length of follow-up. Conclusion This study, the largest one published from a single institution, with a mean follow-up duration of 15 months, confirms that endometrial laser ablation is a safe and effective treatment for dysfunctional uterine bleeding.

A multi‐centre collaborative study into the treatment of menorrhagia by Nd‐YAG laser ablation of the endometrium

Objective— To determine the safety and clinical effectiveness of Nd‐YAG laser ablation of the endometrium in the treatment of menorrhagia.

A double-blind randomized trial comparing the Cavaterm™ and the NovaSure™ endometrial ablation systems for the treatment of dysfunctional uterine bleeding

OBJECTIVE To compare two second-generation endometrial ablation systems in women with dysfunctional uterine bleeding (DUB) who want conservative surgical treatment. DESIGN A double-blind, randomized trial. SETTING A minimal access gynecological surgery unit in northeast England. PATIENT(S) Fifty-seven women diagnosed with DUB were recruited, with 55 undergoing surgery and completing 12-month follow-up. INTERVENTION(S) Thirty-seven women underwent a NovaSure endometrial ablation, and 18 had a Cavaterm endometrial ablation. Clinical and quality of life data were collected 6 and 12 months after treatment. MAIN OUTCOME MEASURE(S) Amenorrhea, menstrual change, quality of life, sexual activity, patient satisfaction, and procedure acceptability. RESULT(S) Amenorrhea, hypomenorrhea, eumenorrhea, and menorrhagia rates for the Cavaterm and Novasure groups at 12 months were 2/18 (11%) vs. 16/37 (43%); 11/18 (61%) vs. 10/37 (27%); 5/18 (27%) vs. 6/37 (16%); and 0/18 vs. 5/37 (13%), respectively. At 12 months, 83% and 92% of women were either satisfied or very satisfied in the Cavaterm or Novasure groups, respectively. There were no major complications in either group. CONCLUSION(S) Both the Cavaterm and the Novasure endometrial ablation systems are effective in reducing menstrual loss in women with DUB and achieve high rates of patient satisfaction. The Novasure system achieved a statistically significantly higher rate of amenorrhea in this study.

Good practice with endometrial ablation

Objective To provide clear guidelines for the safe and effective performance of endometrial ablation. Data Sources Representatives of American, Australian, British, and Canadian hysteroscopists were brought together to produce a consensus document of good practice in endometrial ablation. Methods of Study Selection The guidelines were produced after researching the literature, combining the extensive experience of the group, and debating the relevant issues. Conclusions Endometrial ablation is a new procedure. Correct patient selection is essential in producing good results. Patients must be counseled carefully about the advantages, disadvantages, and potential complications of this approach to the management of menstrual disorders. The main indication for endometrial ablation is heavy menstrual loss in the absence of organic disease. Excessive uterine size, the presence of active pelvic infection, and evidence of malignant and premalignant endometrium are absolute contraindications. Ablation can be produced by electrosurgical resection, rollerball or rollerbarrel ablation and Nd-YAG laser ablation. Severe complications can occur, and techniques should be adopted to avoid uterine perforation, hemorrhage, and excessive fluid absorption. In skilled hands, endometrial ablation can be a safe and effective treatment for menorrhagia.

Cavaterm thermal balloon ablation for the treatment of menorrhagia

Fifty patients due to undergo endometrial ablation as a treatment of dysfunctional uterine bleeding were recruited to assess the efficacy and safety of a new thermal balloon ablation system (Cavaterm). The patients were followed up for a mean of 14 months (range 6–24): 34 (68%) have complete amen‐orrhoea, 12 (24%) only have spotting, two (4%) are eumenorrhoeic, and two (4%) have had failed treatments. There were no major complications, but two patients have required oral antibiotics for suspected endometritis. Although these preliminary results are encouraging, all patients remain under review to determine long term effect of the procedure. Further evaluation is also underway in the form of a randomised trial against endometrial laser ablation.

Sexual activity questionnaires in clinical trials: acceptability to patients with gynaecological disorders

Objective To assess the feasibility and acceptability of including sexual activity questionnaires in gynaecological clinical trials.

A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding

Objective To compare the effectiveness of the Cavaterm thermal balloon endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding.