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

April 26, 2021 updated by: Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

409

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 Locations

  • Germany
    • NRW
      • Münster, NRW, Germany, 48149
        • University hospital Muenster

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
ovariopexy for 2 days
Procedure: ovariopexy
if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall
Experimental: B
ovariopexy for 4 days
Procedure: ovariopexy
if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall
Experimental: C
ovariopexy for 6 days
Procedure: ovariopexy
if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall
Placebo Comparator: D
Placebo Operation for 2 days
Procedure: placebo operation
in arm D sutures are transabdominal only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of postoperative ovarian adhesions
Time Frame: 3 months after operation
prevalence of postoperative ovarian adhesions
3 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: daily during postoperative hospitalisation and at follow up visit after 3 months
postoperative pain (NRS)
daily during postoperative hospitalisation and at follow up visit after 3 months
AMH
Time Frame: at follow up visit after 3 months
AMH level
at follow up visit after 3 months
postoperative infectious complications
Time Frame: up to 3 months after operation
postoperative infectious complications
up to 3 months after operation

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

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)

April 1, 2018

Primary Completion (Actual)

January 8, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Schäfer_Endo_Ovariopexie

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

data can be shared upon reasonable request and according to regulations

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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