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

Study Overview
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Brief Summary
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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

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

Conditions
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Endometriosis, Adhesion, Surgery

Intervention / Treatment
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* Procedure: ovariopexy
* Procedure: placebo operation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ovariopexy for 2 days | Procedure: ovariopexy<br>* 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<br>|
| Experimental: B<br>ovariopexy for 4 days | Procedure: ovariopexy<br>* 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<br>|
| Experimental: C<br>ovariopexy for 6 days | Procedure: ovariopexy<br>* 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<br>|
| Placebo Comparator: D<br>Placebo Operation for 2 days | Procedure: placebo operation<br>* in arm D sutures are transabdominal only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of postoperative ovarian adhesions | prevalence of postoperative ovarian adhesions | 3 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | postoperative pain (NRS) | daily during postoperative hospitalisation and at follow up visit after 3 months | 
| AMH | AMH level | at follow up visit after 3 months | 
| postoperative infectious complications | postoperative infectious complications | up to 3 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, ovariopexy, adhesion prevention, laparoscopy, complications, AMH