NCT04669756

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2.8 years

First QC Date

December 4, 2020

Last Update Submit

April 26, 2021

Conditions

EndometriosisAdhesionSurgery

Keywords

endometriosisovariopexyadhesion preventionlaparoscopycomplicationsAMH

Outcome Measures

Primary Outcomes (1)

  • prevalence of postoperative ovarian adhesions

    prevalence of postoperative ovarian adhesions

    3 months after operation

Secondary Outcomes (3)

  • postoperative pain

    daily during postoperative hospitalisation and at follow up visit after 3 months

  • AMH

    at follow up visit after 3 months

  • postoperative infectious complications

    up to 3 months after operation

Study Arms (4)

A

EXPERIMENTAL

ovariopexy for 2 days

Procedure: ovariopexy

B

EXPERIMENTAL

ovariopexy for 4 days

Procedure: ovariopexy

C

EXPERIMENTAL

ovariopexy for 6 days

Procedure: ovariopexy

D

PLACEBO COMPARATOR

Placebo Operation for 2 days

Procedure: placebo operation

Interventions

ovariopexyPROCEDURE

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

ABC
placebo operationPROCEDURE

in arm D sutures are transabdominal only

D

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

EndometriosisTissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sebastian D Schaefer, MD PhD

    University Hospital Muenster, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gynecology

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 17, 2020

Study Start

April 1, 2018

Primary Completion

January 8, 2021

Study Completion

January 31, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

DE(1)