Surgicel Reduces Ovarian Endometriomas Recurrence

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants were randomized into 4 groups; group A (drainage only) in which 50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B (cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel inside the remaining ovarian tissues.All patients were followed up every 3 months for 2 years following the laparoscopic surgery. The primary outcome was the recurrence of endometriomas in the ipsilateral ovary (recurrence was defined as the presence of ovarian cysts with the characteristic sonographic features of endometriomas (≥1 cm). The ovarian reserve was reassessed (AMH & day 2 AFC) as a secondary outcome 6 months following the laparoscopy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University

Criteria

Inclusion Criteria:

• Endometriosis-related clinical manifestations (infertility, pelvic pain or pelvic mass)

• Unilateral & unilocular endometrioma (≥5 cm),

• Rapidly growing endometrioma

• Good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml & antral follicular count {AFC} > 4).

Exclusion Criteria:

• Recurrent & bilateral cases

• Patients who were unfit for surgery, suffered chronic diseases (e.g. cardiac disease or diabetes)

• PATIENTS had any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring) .