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

NCT ID: NCT04669756

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Endometriosis Adhesion Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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A

ovariopexy for 2 days

Group Type EXPERIMENTAL

ovariopexy

Intervention Type PROCEDURE

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

B

ovariopexy for 4 days

Group Type EXPERIMENTAL

ovariopexy

Intervention Type PROCEDURE

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

C

ovariopexy for 6 days

Group Type EXPERIMENTAL

ovariopexy

Intervention Type PROCEDURE

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

D

Placebo Operation for 2 days

Group Type PLACEBO_COMPARATOR

placebo operation

Intervention Type PROCEDURE

in arm D sutures are transabdominal only

Interventions

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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

Intervention Type PROCEDURE

placebo operation

in arm D sutures are transabdominal only

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Sebastian Daniel Schäfer

Head of Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sebastian D Schaefer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster, Germany

Locations

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University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Schäfer_Endo_Ovariopexie

Identifier Type: -

Identifier Source: org_study_id

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