Laparoscopic Myomectomy Using Barbed or Conventional Sutures . A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Fibroid
- Sponsor
- Cairo University
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Operative time
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .
Detailed Description
• Till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .The myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . The operative time was shorter in the barbed suture group (73.3 ± 21.4 min Vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . However, the time required to suture the myoma beds was significantly lower in the barbed suture group .
Investigators
Usama M Fouda
M.D, PhD
Cairo University
Eligibility Criteria
Inclusion Criteria
- •the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm).
Exclusion Criteria
- •submucosal myoma
- •calcified myomas
- •uterine size more than 16 weeks
- •suspension of genital malignancy
- •coagulation defects or concurrent anticoagulant therapy
- •pregnancy
- •compromised cardiopulmonary status
- •previous treatment with gonadotropin-releasing hormone analogue
- •contraindications for general anesthesia.
Outcomes
Primary Outcomes
Operative time
Time Frame: During myomectomy operation
Secondary Outcomes
- Suturing time of myoma bed(During myomectomy operation)