Abstract
BackgroundEndometriosis is a common benign condition, which is characterized by the growth of endometrial-like tissue in ectopic sites outside the uterus. Laparoscopic excision of the disease is frequently carried out for the treatment of severe endometriosis. Pelvic adhesions often develop following surgery and they can compromise the success of treatment. Ovarian suspension (elevating both ovaries to the anterior abdominal wall using a Prolene suture) is a simple procedure which has been used to facilitate ovarian retraction during surgery for severe pelvic endometriosis. The study aims to assess the effect of temporary ovarian suspension following laparoscopic surgery for severe pelvic endometriosis on the prevalence of post-operative ovarian adhesions.MethodsA prospective double blind randomised controlled trial for patients with severe pelvic endometriosis requiring extensive laparoscopic dissection with preservation of the uterus and ovaries. Severity of the disease and eligibility for inclusion will be confirmed at surgery. Patients unable to provide written consent, inability to tolerate a transvaginal ultrasound scan, unsuccessful surgeries or suffer complications leading to oophorectomies, bowel injuries or open surgery will be excluded.Both ovaries are routinely suspended to the anterior abdominal wall during surgery. At the end of the operation, each participant will be randomised to having only one ovary suspended post-operatively. A new transabdominal suture will be reinserted to act as a placebo. Both sutures will be cut 36 to 48 hours after surgery before the woman is discharged home. Three months after surgery, all randomised patients will have a transvaginal ultrasound scan to assess for ovarian mobility. Both the patients and the person performing the scan will be blinded to the randomisation process.The primary outcome is the prevalence of ovarian adhesions on ultrasound examination. Secondary outcomes are the presence, intensity and site of post-operative pain.DiscussionThis controlled trial will provide evidence as to whether temporary ovarian suspension should be included into the routine surgical treatment of women with severe pelvic endometriosis.Trial registrationISRCTN: ISRCTN24242218
Highlights
Endometriosis is a common benign condition, which is characterized by the growth of endometrium-like tissue in ectopic sites outside the uterus
Formation of severe post-operative adhesions can compromise the success of surgery for endometriosis by causing chronic pelvic pain, infertility, dysparaeunia and intestinal obstruction [5]
Interventions During laparoscopic treatment for severe endometriosis, both ovaries are routinely suspended to the anterior abdominal wall using a Prolene suture, which is brought out onto the skin and secured using a fine haemostat or ‘mosquito’ clip during surgery
Summary
Interventions During laparoscopic treatment for severe endometriosis, both ovaries are routinely suspended to the anterior abdominal wall using a Prolene suture, which is brought out onto the skin and secured using a fine haemostat or ‘mosquito’ clip during surgery. There will be no documentation of the randomisation site in the operation notes Both sutures will be cut 36 to 48 hours after surgery by a ward nurse who will not be part of the study and will be blinded to the ovarian suspension site. Statistical analysis Women with bilateral endometriosis will receive the normal surgical treatment with the difference that one ovary will be randomised to ovarian suspension and the other to non-suspension. Pilot study A pilot study was conducted to determine the prevalence of ovarian adhesion on transvaginal ultrasound three months after routine laparoscopic treatment of severe pelvic endometriosis (without ovarian suspension). Allowing for a possible 10% dropout during the follow up period, we plan to recruit 50 patients for the study
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