Jeremy Hawe

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.

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.

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.

Recurrent pain after hysterectomy and bilateral salpingo-oophorectomy for endometriosis: evaluation of laparoscopic excision of residual endometriosis

Endometriosis can represent with a variety of symptoms including pelvic pain, dyspareunia and pain with defaecation, up to several years after hysterectomy and bilateral salpingo‐oophorectomy. This may occur when all endometriotic tissue is not excised at the time of the initial procedure. Although excision of endometriosis at this time would be preferable, we have found laparoscopic excision of residual endometriosis to be effective in relieving endometriosis associated pain.

Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial.

OBJECTIVE To determine whether a drain placed in the peritoneal cavity during laparoscopy is both a clinical and cost‐effective method of reducing postoperative pain. METHODS Two hundred twenty‐five women undergoing diagnostic or minor operative laparoscopic procedures were recruited. Women were assigned to receive either an intraperitoneal gas drain or a dummy drain during surgery. Sample size to detect a two‐point difference in visual analogue score was estimated at 158 subjects, with 79 in each arm. The patients and nursing staff were unaware of the position of the drain. A visual analogue score was used to assess pain preoperatively and at 4, 24, and 48 hours postoperatively. Data on the experience of nausea, frequency of vomiting, and site of pain were collected. The analgesic and antiemetic use was recorded. An economic evaluation of the analgesic use and the material costs for the two groups was performed. RESULTS One hundred sixty‐one complete sets of data (72%) were available for analysis. The two groups were well matched for age, parity, previous surgery, body mass index, volume of carbon dioxide used, and operative time. No significant differences were found between the two groups with regard to the overall pain scores preoperatively (8 versus 7) or at 4 (30 versus 34), 24 (40 versus 44), and 48 (26 versus 26) hours postoperatively, after adjusting for multiple point testing. On assessment at different sites, the dummy drain group experienced shoulder pain more frequently at 4 (19 of 79 versus 10 of 82, P = .05) and 48 (16 of 79 versus 7 of 82, P = .03) hours postoperatively compared with the drain group. The placebo group had a 33% greater usage of oral analgesia after discharge, but this was

Endometrial laser intrauterine thermotherapy for the treatment of dysfunctional uterine bleeding: the first British experience

2.50 cheaper than the use of an intraperitoneal drain. No statistically significant differences were found between the groups with regard to nausea and vomiting postoperatively. CONCLUSION An intraperitoneal drain after minor gynecologic laparoscopy decreases the frequency of shoulder pain and reduces postoperative analgesia requirements. However, it is less cost‐effective to reduce pain using an intraperitoneal gas drain than simple oral analgesia after minor gynecologic laparoscopy.

Laparoscopic-assisted Doderlein hysterectomy: retrospective analysis of 300 consecutive cases

Forty patients due to undergo endometrial ablation as a treatment for dysfunctional uterine bleeding were recruited to assess the efficacy and safety of endometrial laser intrauterine thermo‐therapy using the gynelase. At 12 months the average menstrual score reduction was 88%, the amenorrhoea rate was 70%, and the hypomenorrhoea rate 16%. Four women (10%) have had a hysterectomy for persistent menorrhagia, and one (3%) for pelvic pain. One patient (3%) has had a further endometrial laser ablation. There were no major complications, and 34 patients (85%) were most satisfied with the treatment. The system is easy to use and has a short learning curve.

Results of eVALuate study of hysterectomy techniques: Authors' reply.

Objective To assess the clinical outcomes of the Doderlein laparoscopic‐assisted hysterectomy.

The effects and effectiveness of laparoscopic excision of endometriosis: a prospective study with 2–5 year follow‐up

EDITOR—Given the pre-eminent role of gynaecologists in developing both operative laparoscopy and randomised trials, we were astonished that we might need a gastrointestinal surgeon in our team. Many of our team were, however, intuitively empathetic with Atkinsons concern that preoperative conversion should not be considered a major complication. To exclude patients who did not receive the planned treatment would alter the complication rates and represent a post-randomisation selection bias in favour of laparoscopic hysterectomy. …