Adhesion, Endometriosis, Surgery
Conditions
Keywords
endometriosis, ovariopexy, adhesion prevention, laparoscopy, complications, AMH
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
Interventions
PROCEDUREovariopexy
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
PROCEDUREplacebo operation
in arm D sutures are transabdominal only
Sponsors
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of postoperative ovarian adhesions | 3 months after operation | prevalence of postoperative ovarian adhesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | daily during postoperative hospitalisation and at follow up visit after 3 months | postoperative pain (NRS) |
| AMH | at follow up visit after 3 months | AMH level |
| postoperative infectious complications | up to 3 months after operation | postoperative infectious complications |
Countries
Germany
Outcome results
None listed