Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy

Phase 2

• Conditions: Hysterectomy
• Interventions: Device: Vaginal cuff closure using barbed sutures; Device: Vaginal cuff closure using conventional sutures

• Registration Number: NCT02998658
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to estimate whether the use of the barbed suture facilitates laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.

Detailed Description

Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (0.3-3.1 %) compared to abdominal and vaginal hysterectomy

Barbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When compared with conventional smooth suture, barbed suture has external barbs that anchor the suture to the tissues and prevent the retrograde movement of suture thread during suturing. Consequently, laparoscopic suturing can be performed easily without the need for suture locking, without applying traction on suture thread by the assistant and without tying knots at both ends of the suture line In gynecology, barbed sutures have been used in minimally invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic suturing and significantly reduces suturing time, total operating time and intraoperative blood loss To date only two small randomized controlled trials compared the effectiveness of the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20
• Study Start: 2017-02
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)

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Exclusion Criteria

• Genital malignancy
• Uterine size more than 16 weeks
• Coagulation defects or concurrent anticoagulant therapy
• Pregnancy
• Compromised cardiopulmonary status
• Contraindications for general anesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal cuff closure using barbed sutures	Vaginal cuff closure using barbed sutures	Vaginal cuff is closed with barbed sutures
Vaginal cuff closure using conventional sutures	Vaginal cuff closure using conventional sutures	Vaginal cuff is closed with conventional sutures

Primary Outcome Measures

Name	Time	Method
Suturing time of vaginal cuff	During hysterectomy operation

Secondary Outcome Measures

Name	Time	Method
Operative time	During hysterectomy operation

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Caene, Egypt