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Completed

NCT Number: NCT04669756

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

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

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Key information

Conditions

Endometriosis Adhesion Cicatrix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery Tissue Adhesions Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ovariopexy

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

placebo operation

Procedure

in arm D sutures are transabdominal only

Primary outcomes

  1. prevalence of postoperative ovarian adhesions

    Time frame: 3 months after operation

    prevalence of postoperative ovarian adhesions

Secondary outcomes

  1. postoperative pain

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

    postoperative pain (NRS)

  2. AMH

    Time frame: at follow up visit after 3 months

    AMH level

  3. postoperative infectious complications

    Time frame: up to 3 months after operation

    postoperative infectious complications

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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