Laparoscopic Myomectomy Using Barbed or Conventional Sutures

Phase 2

Completed

• Conditions: Fibroid
• Interventions: Procedure: myomectomy using barbed sutures; Procedure: myomectomy using conventional sutures

• Registration Number: NCT02166411
• Lead Sponsor: Cairo University

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 .

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Primary Completion: 2019-01
• Status Verified: 2019-10
• Study Completion: 2020-01
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myomectomy using barbed sutures	myomectomy using barbed sutures	.Myoma bed is sutured with barbed sutures
myomectomy using conventional sutures	myomectomy using conventional sutures	Myoma bed is sutured with conventional sutures

Primary Outcome Measures

Name	Time	Method
Operative time	During myomectomy operation

Secondary Outcome Measures

Name	Time	Method
Suturing time of myoma bed	During myomectomy operation

Trial Locations

Locations (1)

Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university; 🇪🇬 Cairo, Egypt