NCT02998658

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

Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hysterectomy

Interventions

Type	Name	Description
DEVICE	Vaginal cuff closure using barbed sutures	Vaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA )
DEVICE	Vaginal cuff closure using conventional sutures	Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2016-12-20
• Last updated: 2016-12-20

Locations

1 site across 1 country: Egypt