Does ovarian suspension following laparoscopic surgery for endometriosis reduce postoperative adhesions? An RCT.

STUDY QUESTION: Is temporary ovarian suspension following laparoscopic surgery for severe pelvic endometriosis an effective method for reducing the prevalence of postoperative ovarian adhesions? SUMMARY ANSWER: Temporary ovarian suspension for 36-48 h following laparoscopic treatment of severe endometriosis does not result in a significant reduction of postoperative ovarian adhesions. WHAT IS KNOWN ALREADY: Pelvic adhesions often develop following laparoscopic surgery for severe pelvic endometriosis. Adhesions can cause chronic pelvic pain and fertility problems compromising the success of treatment. Small observational studies suggested that temporary postoperative ovarian suspension to the abdominal wall may significantly reduce the prevalence of postoperative ovarian adhesions. STUDY DESIGN, SIZE, DURATION: This was a prospective within group comparison double-blind RCT. We recruited premenopausal women with severe pelvic endometriosis who required extensive laparoscopic surgery with preservation of the uterus and ovaries. Severity of the disease and eligibility for inclusion were determined at surgery. A total of 55 women were randomized to unilateral ovarian suspension for 36-48 h, 52 of which were included in the final analysis. Both ovaries were routinely suspended to the anterior abdominal wall during surgery. At the end of the operation, each woman was randomized to having only one ovary suspended postoperatively. The suture suspending the contralateral ovary was cut and a new transabdominal suture was inserted to act as a placebo. Both sutures were removed 36-48 h after surgery prior to discharge. Three months after surgery, all women attended for a detailed transvaginal ultrasound scan to assess ovarian mobility. Both the women and the ultrasound operators were blinded as to the side of postoperative ovarian suspension. The primary outcome was the prevalence of ovarian adhesions as described on ultrasound examination. Secondary outcomes were the severity of adhesions and the presence and intensity of postoperative pain. PARTICIPANTS/MATERIALS, SETTING,
METHODS: All 55 participants had severe pelvic endometriosis confirmed at laparoscopy. As each participant had only one of their ovaries suspended at the end of surgery, they acted as their own control. MAIN RESULTS AND THE ROLE OF CHANCE: The median interval between ovarian suspension and postoperative scan was 99 days (interquartile range 68-114). There was no significant difference (P = 0.23) in the prevalence of postoperative ovarian adhesions between the suspended (20/52) and unsuspended (27/52) side (38.5 versus 51.9%) [odds ratio 0.56 (95% confidence interval 0.22-1.35)]. LIMITATIONS, REASONS FOR CAUTION: Ovaries were suspended postoperatively for 36-48 h. Longer suspension could result in lower prevalence of postoperative adhesions. WIDER IMPLICATIONS OF THE
FINDINGS: The value of temporary ovarian suspension in women having surgery for mild-to-moderate endometriosis should be investigated further. The potential benefits of other adhesion prevention strategies, such as surgical barrier agents, in women undergoing surgical treatment for severe pelvic endometriosis should also be explored. STUDY FUNDING/COMPETING INTERESTS: E.S. received honoraria from Ethicon for provision of training to healthcare professionals and consultancy fees from Bayer. W.H. was supported by the research fund provided by the Gynaecology Ultrasound Centre, London UK. A.C. is on the advisory board for surgical innovations for which he receives an annual honorarium. A.C. also received support for courses and education from Storz and Johnson and Johnson and support for clinical nursing from Covidien and Lotus. The other authors declared no competing interests. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN24242218.

RCT Entities:   Population Interventions Outcomes