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

U

University Hospital Muenster

Status

Completed

Conditions

Adhesion
Surgery
Endometriosis

Treatments

Procedure: ovariopexy
Procedure: placebo operation

Study type

Interventional

Funder types

Other

Identifiers

NCT04669756
Schäfer_Endo_Ovariopexie

Details and patient eligibility

About

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

Enrollment

409 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

409 participants in 4 patient groups, including a placebo group

A
Experimental group
Description:
ovariopexy for 2 days
Treatment:
Procedure: ovariopexy
B
Experimental group
Description:
ovariopexy for 4 days
Treatment:
Procedure: ovariopexy
C
Experimental group
Description:
ovariopexy for 6 days
Treatment:
Procedure: ovariopexy
D
Placebo Comparator group
Description:
Placebo Operation for 2 days
Treatment:
Procedure: placebo operation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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