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

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ClinicalTrials.gov Identifier: NCT04669756
Recruitment Status : Completed
First Posted : December 17, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster

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

Condition or disease Intervention/treatment Phase
Endometriosis Adhesion Surgery Procedure: ovariopexy Procedure: placebo operation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 409 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : January 8, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
ovariopexy for 2 days
Procedure: 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

Experimental: B
ovariopexy for 4 days
Procedure: 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

Experimental: C
ovariopexy for 6 days
Procedure: 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

Placebo Comparator: D
Placebo Operation for 2 days
Procedure: placebo operation
in arm D sutures are transabdominal only




Primary Outcome Measures :
  1. prevalence of postoperative ovarian adhesions [ Time Frame: 3 months after operation ]
    prevalence of postoperative ovarian adhesions


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669756


Locations
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Germany
University Hospital Muenster
Münster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Sebastian D Schaefer, MD PhD University Hospital Muenster, Germany
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Responsible Party: Dr. med. Sebastian Daniel Schäfer, Head of Gynecology, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04669756    
Other Study ID Numbers: Schäfer_Endo_Ovariopexie
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data can be shared upon reasonable request and according to regulations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster:
endometriosis
ovariopexy
adhesion prevention
laparoscopy
complications
AMH
Additional relevant MeSH terms:
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Endometriosis
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes