Pelvic adhesions, particularly between ovaries and pelvic sidewall, frequently complicate endometriosis surgery. Despite various interventions, no widely accepted solution exists. Small studies suggest temporary ovarian suspension may reduce adhesion formation. This technique, which temporarily elevates ovaries postoperatively, shows promise but requires further investigation to confirm its efficacy and long-term outcomes.
This prospective, single-blinded, randomized controlled study compares adhesion formation in endometriosis patients at risk for ovarian adhesions. Participants are randomized to undergo laparoscopic surgery with temporary ovarian suspension or standard care without ovarian suspension. Pain and suture removal eagerness are assessed via daily questionnaires. Blinded ultrasound experts evaluate adhesions at 6 and 13 weeks postoperatively. No anti-adhesive barriers are used to minimize confounding factors
Patients with moderate to severe endometriosis with suspected adhesions, lesions in the ovary, ovarian fossa, utero-sacral ligaments, pouch of douglas, or involvement of the intestine as seen in preoperative assessment who are willing to participate in the study including postoperative follow-up assessments.
Patients who are not intended to have an endometriosis operation. Patients with minimal to mild endometriosis and no suspected adhesions or ovarian, ovarian fossa, utero-sacral ligament, pouch of douglas involvement on preoperative assessment.
Parallel
laparoscopic ovarian suspension
Procedure/SurgerySuspension of the ovary during laparoscopy for endometriosis
Adhesion formation following laparoscopic surgery with temporary ovarian suspension as assessed in post-operative ultrasound visits at weeks 6,13 following surgery
The primary objective of the study is to examine adhesion formation following laparoscopic surgery with temporary ovarian suspension removed a week after surgery. Assessment of adhesions will be performed by ultrasound before surgery and then at 6 week and 13-week post-surgery. Assessment will be performed by an ultrasound specialist who is blinded to the surgical procedure. Adhesions are marked as negative or positive per organ including left and right ovary, left and right tube and other locations (rectosigmoid, uterus, bladder, pouch of Douglas).
Patient pain during the first week following laparoscopy
The secondary objective is to analyze patient pain symptoms during the first week after surgery. Patients will report pain symptoms daily, as measured by Visual Analog Score for pain on a scale of 0-10.
Patient tolerability to ovarian suspension during the first week following surgery
Patient will report daily on their eagerness to remove the suture temporarily suspending each ovary to the abdominal wall on a scale from 0 to 10 during the first week after surgery.
Click on the lead sponsor to view all of their trials.
