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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669756
• Other study ID #: Schäfer_Endo_Ovariopexie
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: January 31, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesion
• Endometriosis
• Surgery
• Tissue Adhesions

Intervention

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 operation
in arm D sutures are transabdominal only

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of postoperative ovarian adhesions	prevalence of postoperative ovarian adhesions	3 months after operation
Secondary	postoperative pain	postoperative pain (NRS)	daily during postoperative hospitalisation and at follow up visit after 3 months
Secondary	AMH	AMH level	at follow up visit after 3 months
Secondary	postoperative infectious complications	postoperative infectious complications	up to 3 months after operation