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

NCT07087756 | Recruiting

• 1 other identifier: CMC-0110-24
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis; Abdominal Adhesions

Keywords

endometriosis; ovarian suspension; laparoscopy; abdominal adhesions

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to last follow-up visit at 13 weeks post surgery

Secondary Outcomes (2)

• Patient pain during the first week following laparoscopy

  From enrollment to 1 week post-operative follow-up visit

• Patient tolerability to ovarian suspension during the first week following surgery

  From enrollment to 1 week post-operative follow-up visit

Study Arms (2)

Suspended Ovary

ACTIVE COMPARATOR

Ovary suspended during laparoscopy for endometriosis surgery

Procedure: laparoscopic ovarian suspension

Non-suspended ovary

SHAM COMPARATOR

Ovaries not suspended during laparoscopy for endometriosis

Procedure: laparoscopic ovarian suspension

Interventions

laparoscopic ovarian suspension PROCEDURE

Suspension of the ovary during laparoscopy for endometriosis

Non-suspended ovary; Suspended Ovary

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Related Publications (10)

• Davey AK, Maher PJ. Surgical adhesions: a timely update, a great challenge for the future. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):15-22. doi: 10.1016/j.jmig.2006.07.013.

  PMID: 17218224 BACKGROUND

• Hudelist G, Fritzer N, Staettner S, Tammaa A, Tinelli A, Sparic R, Keckstein J. Uterine sliding sign: a simple sonographic predictor for presence of deep infiltrating endometriosis of the rectum. Ultrasound Obstet Gynecol. 2013 Jun;41(6):692-5. doi: 10.1002/uog.12431.

  PMID: 23400893 BACKGROUND

• diZerega GS, Campeau JD. Peritoneal repair and post-surgical adhesion formation. Hum Reprod Update. 2001 Nov-Dec;7(6):547-55. doi: 10.1093/humupd/7.6.547.

  PMID: 11727863 BACKGROUND

• Kavic SM, Kavic SM. Adhesions and adhesiolysis: the role of laparoscopy. JSLS. 2002 Apr-Jun;6(2):99-109.

  PMID: 12113430 BACKGROUND

• diZerega GS. Contemporary adhesion prevention. Fertil Steril. 1994 Feb;61(2):219-35. doi: 10.1016/s0015-0282(16)56507-8.

  PMID: 8299773 BACKGROUND

• Mabrouk M, Montanari G, Guerrini M, Villa G, Solfrini S, Vicenzi C, Mignemi G, Zannoni L, Frasca C, Di Donato N, Facchini C, Del Forno S, Geraci E, Ferrini G, Raimondo D, Alvisi S, Seracchioli R. Does laparoscopic management of deep infiltrating endometriosis improve quality of life? A prospective study. Health Qual Life Outcomes. 2011 Nov 6;9:98. doi: 10.1186/1477-7525-9-98.

  PMID: 22054310 BACKGROUND

• Ouahba J, Madelenat P, Poncelet C. Transient abdominal ovariopexy for adhesion prevention in patients who underwent surgery for severe pelvic endometriosis. Fertil Steril. 2004 Nov;82(5):1407-11. doi: 10.1016/j.fertnstert.2004.03.060.

  PMID: 15533368 BACKGROUND

• Garry R, Clayton R, Hawe J. The effect of endometriosis and its radical laparoscopic excision on quality of life indicators. BJOG. 2000 Jan;107(1):44-54. doi: 10.1111/j.1471-0528.2000.tb11578.x.

  PMID: 10645861 BACKGROUND

• Garry R. Laparoscopic excision of endometriosis: the treatment of choice? Br J Obstet Gynaecol. 1997 May;104(5):513-5. doi: 10.1111/j.1471-0528.1997.tb11523.x. No abstract available.

  PMID: 9166188 BACKGROUND

• Farquhar C. Endometriosis. BMJ. 2007 Feb 3;334(7587):249-53. doi: 10.1136/bmj.39073.736829.BE. No abstract available.

  PMID: 17272567 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Yuval Kaufman, MD

CONTACT

+97248250336; mdykaufman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Multidisciplinary Center for the Treatment of Endometriosis

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 28, 2025
• Study Start: March 16, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data available from 26/6/2025 till study termination estimated at around 1/7/2025

Locations

IL (1)