The Effect of Temporary Ovarian Suspension to the Abdominal Wall During Laparoscopic Endometriosis Surgery for Adhesion Prevention -A Comparative and Prospective Study

July 19, 2025 updated by: Yuval Kaufman, Carmel Medical Center

The Effect of Temporary Ovarian Suspension to the Anterior Abdominal Wall During Laparoscopic Endometriosis Surgery for Adhesion Prevention -A Comparative and Prospective Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a chronic condition characterized by growth of endometrial tissue in sites other than the uterine cavity, most commonly in the pelvic cavity, including the ovaries, the uterosacral ligaments, and the pouch of Douglas. Laparoscopic excision of endometriosis lesions has become the gold standard treatment. At follow-up, relief of pain and quality of life after endometriosis surgical treatment ranges between 50% and 95%. However, pelvic surgery for endometriosis has been associated with a high rate of postoperative adhesion formation. The incidence of pelvic adhesions at second-look laparoscopy in the initial few weeks after surgery has been reported to be between 50% and 100%. The ovaries are the most common site involved by adhesions because of their anatomic localization (close to the pelvic sidewall and the homolateral tube) and the fragility of the coelomic epithelium that covers the ovarian surface [7,8]. In addition, when the posterior pelvic compartment is involved, obliteration of the pouch of Douglas is often observed as a result of a post-inflammatory process causing ovarian adhesions [9]. Women with higher risk for postoperative ovarian adhesions include those who have preoperative ovarian adhesions or patients undergoing ovarian cystectomy, peritonectomy of the ovarian fossa or extensive pelvic adhesiolysis. Postoperative retained free fluid with blood and postoperative infections may also increase the risk for adhesions. Postoperative adhesions are a source of major concern because of their potential consequences including persistent pelvic pain, dyspareunia (difficult or painful sexual intercourse), infertility, intestinal obstruction, and complications at subsequent surgery.

A wide range of interventions has been tried in the past in order to reduce postoperative pelvic adhesions. This includes intra-peritoneal administration of anti-adhesive solutions such as icodextrin and hyaluronic acid. Various drugs including steroids and heparin have also been tried in the past but none of them have gained wide acceptance (Metwally et al., 2006; Kamel, 2010). Oxidized regenerated cellulose was found to reduce postoperative adhesion in two very small RCTs (Ahmad et al., 2008).

Intra-operative suspension of the ovaries to the anterior abdominal wall is sometimes used to facilitate ovarian retraction and improve exposure of the pelvis during surgery for severe endometriosis (Cutner et al., 2004). Temporary ovarian suspension can be achieved using a straight needle and absorbable suture to suspend the ovary to the abdominal wall with an external knot tie that can be easily removed at any time after surgery. Two small observational studies suggested that temporary ovarian suspension for 4-7 days following surgery for severe endometriosis may reduce the frequency of postoperative pelvic adhesions (Abuzeid et al., 2002; Ouahba et al., 2004).

The Objective of the Study The primary objective of the study is to examine adhesion formation following laparoscopic surgery with temporary ovarian suspension removed a week after surgery.

The secondary objective is the analyze patient symptoms and adherence to the ovarian suspension as well as request to remove the suture before one week post operative.

Rationale for conducting the study If ovarian suspension is indeed beneficial it can be incorporated as part of common practice for laparoscopic endometriosis surgery.

Methods This is a prospective single-blinded randomized controlled interventional study.

Patients scheduled for laparoscopic surgery due to endometriosis with suspected adnexal adhesions, lesions of the ovary, ovarian fossa, uterosacral ligaments, pouch of Douglas, or involvement of the bowel, as seen by imaging, will be included. A comparison will be made between suspended ovaries in the study group vs. non-suspended ovaries in the control group. During surgery, the primary surgeon will inspect the pelvis. If on the side of the relevant ovary there are adhesions and/or ovarian cyst and/or peritoneal lesions around the ovarian fossa and uterosacral ligament, an ovarian suspension will be performed according to randomization. The randomization process will be based on a preformed list produced by the statistician which will be used during surgery. In case of bilateral pelvic involvement, the left ovary will be the first to be acted on according to the randomization result (i.e suspend/not suspend). In case of ovarian cysts, the surgeon will decide upon treatment method of the cyst during surgery. Suspension of the ovary will be performed using Monocryl absorbable suture. In order to reduce confounding variables, there will be no use of anti-adhesive barriers. Removal of the suspension will be performed at the clinic a week after surgery unless the patient requests to remove the suture earlier. Patients will be asked to fill a daily questionnaire describing the amount of pain according to VAS score they are experiencing due to ovarian suspension and how eager they are to remove the suture prematurely on a scale of 1-10.

Preoperative and postoperative ultrasound evaluation will be performed by one of two dedicated ultrasound experts using a Voluson E10 ultrasound. During postoperative evaluation, the experts will be blinded as to whether ovarian suspension was performed or not. Postoperative ultrasound will be performed 6 and 13 weeks following surgery and will include description of the size of the ovary, location and severity of adhesions.

Statistical analysis will be performed according to each suspended vs non-suspended ovary, i.e. the number of ovaries suspended for the study group vs, the number of non-suspended ovaries in the control group patients.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 34362
        • Recruiting
        • Carmel Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suspended Ovary
Ovary suspended during laparoscopy for endometriosis surgery
Procedure: laparoscopic ovarian suspension
Suspension of the ovary during laparoscopy for endometriosis
Sham Comparator: Non-suspended ovary
Ovaries not suspended during laparoscopy for endometriosis
Procedure: laparoscopic ovarian suspension
Suspension of the ovary during laparoscopy for endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesion formation following laparoscopic surgery with temporary ovarian suspension as assessed in post-operative ultrasound visits at weeks 6,13 following surgery
Time Frame: From enrollment to last follow-up visit at 13 weeks post 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).
From enrollment to last follow-up visit at 13 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient pain during the first week following laparoscopy
Time Frame: From enrollment to 1 week post-operative follow-up visit
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.
From enrollment to 1 week post-operative follow-up visit
Patient tolerability to ovarian suspension during the first week following surgery
Time Frame: From enrollment to 1 week post-operative follow-up visit
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.
From enrollment to 1 week post-operative follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 26, 2025

First Submitted That Met QC Criteria

July 19, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 19, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-0110-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients outcomes

IPD Sharing Time Frame

Data available from 26/6/2025 till study termination estimated at around 1/7/2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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