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CompletedNCT04669756Updated Apr 28, 2021

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

An interventional study of ovariopexy and placebo operation in Endometriosis, Adhesion and Surgery, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by University Hospital Muenster · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Apr 2018, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
409
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Endometriosis
  • Adhesion
  • Surgery

Keywords

  • endometriosis
  • ovariopexy
  • adhesion prevention
  • laparoscopy
  • complications
  • AMH
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 409 is above the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
409 participants (actual)

Study arms

  • Experimental
    A

    ovariopexy for 2 days

    Procedure: ovariopexy

  • Experimental
    B

    ovariopexy for 4 days

    Procedure: ovariopexy

  • Experimental
    C

    ovariopexy for 6 days

    Procedure: ovariopexy

  • Placebo comparator
    D

    Placebo Operation for 2 days

    Procedure: placebo operation

Interventions

  • Procedureovariopexy

    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

  • Procedureplacebo operation

    in arm D sutures are transabdominal only

06

What researchers measure

Primary outcomes

  1. prevalence of postoperative ovarian adhesions

    prevalence of postoperative ovarian adhesions

    Time frame: 3 months after operation

Secondary outcomes

  1. postoperative pain

    postoperative pain (NRS)

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

  2. AMH

    AMH level

    Time frame: at follow up visit after 3 months

  3. postoperative infectious complications

    postoperative infectious complications

    Time frame: up to 3 months after operation

07

Study locations

1 site
  • University Hospital Muenster
    Münster, NRW 48149, Germany
08

References and documents

Individual participant data

Plan to share: Undecided — data can be shared upon reasonable request and according to regulations

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04669756
Lead sponsor
University Hospital Muenster
Responsible party
Dr. med. Sebastian Daniel Schäfer (Head of Gynecology, University Hospital Muenster) — Principal investigator
First posted
Dec 17, 2020
Start date
Apr 1, 2018
Primary completion
Jan 8, 2021
Completion
Jan 31, 2021
Last update
Apr 28, 2021

Study contacts

Sebastian D Schaefer, MD PhD
principal investigator · University Hospital Muenster, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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