search
Back to results

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

Primary Purpose

Endometriosis, Adhesion, Surgery

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ovariopexy
placebo operation
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometriosis focused on measuring endometriosis, ovariopexy, adhesion prevention, laparoscopy, complications, AMH

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Muenster

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

ovariopexy for 2 days

ovariopexy for 4 days

ovariopexy for 6 days

Placebo Operation for 2 days

Outcomes

Primary Outcome Measures

prevalence of postoperative ovarian adhesions
prevalence of postoperative ovarian adhesions

Secondary Outcome Measures

postoperative pain
postoperative pain (NRS)
AMH
AMH level
postoperative infectious complications
postoperative infectious complications

Full Information

First Posted
December 4, 2020
Last Updated
April 26, 2021
Sponsor
University Hospital Muenster
search

1. Study Identification

Unique Protocol Identification Number
NCT04669756
Brief Title
Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Official Title
Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Adhesion, Surgery
Keywords
endometriosis, ovariopexy, adhesion prevention, laparoscopy, complications, AMH

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
ovariopexy for 2 days
Arm Title
B
Arm Type
Experimental
Arm Description
ovariopexy for 4 days
Arm Title
C
Arm Type
Experimental
Arm Description
ovariopexy for 6 days
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
Placebo Operation for 2 days
Intervention Type
Procedure
Intervention Name(s)
ovariopexy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
placebo operation
Intervention Description
in arm D sutures are transabdominal only
Primary Outcome Measure Information:
Title
prevalence of postoperative ovarian adhesions
Description
prevalence of postoperative ovarian adhesions
Time Frame
3 months after operation
Secondary Outcome Measure Information:
Title
postoperative pain
Description
postoperative pain (NRS)
Time Frame
daily during postoperative hospitalisation and at follow up visit after 3 months
Title
AMH
Description
AMH level
Time Frame
at follow up visit after 3 months
Title
postoperative infectious complications
Description
postoperative infectious complications
Time Frame
up to 3 months after operation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian D Schaefer, MD PhD
Organizational Affiliation
University Hospital Muenster, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Muenster
City
Münster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
data can be shared upon reasonable request and according to regulations

Learn more about this trial

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

We'll reach out to this number within 24 hrs