Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary

Not Applicable

Completed

• Conditions: Adhesion; Endometriosis; Surgery
• Interventions: Procedure: placebo operation; Procedure: ovariopexy

• Registration Number: NCT04669756
• Lead Sponsor: University Hospital Muenster

Brief Summary

prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-17
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 409

Inclusion Criteria

• premenopausal
• wants to participate
• removal of endometriosis of the pelvic side wall or ovary

Exclusion Criteria

• postmenopausal
• cannot give informed consent
• no endometriosis during Operation
• no Opening of pelvic side wall or ovary during the Operation
• pregnant
• breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D	placebo operation	Placebo Operation for 2 days
A	ovariopexy	ovariopexy for 2 days
B	ovariopexy	ovariopexy for 4 days
C	ovariopexy	ovariopexy for 6 days

Primary Outcome Measures

Name	Time	Method
prevalence of postoperative ovarian adhesions	3 months after operation	prevalence of postoperative ovarian adhesions

Secondary Outcome Measures

Name	Time	Method
postoperative infectious complications	up to 3 months after operation	postoperative infectious complications
postoperative pain	daily during postoperative hospitalisation and at follow up visit after 3 months	postoperative pain (NRS)
AMH	at follow up visit after 3 months	AMH level

Trial Locations

Locations (1)

University Hospital Muenster; 🇩🇪 Münster, NRW, Germany