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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hysterectomy

Intervention / Treatment
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* Device: Vaginal cuff closure using barbed sutures
* Device: Vaginal cuff closure using conventional sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms) Exclusion Criteria: Genital malignancy Uterine size more than 16 weeks Coagulation defects or concurrent anticoagulant therapy Pregnancy Compromised cardiopulmonary status Contraindications for general anesthesia

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal cuff closure using barbed sutures<br>Vaginal cuff is closed with barbed sutures | Device: Vaginal cuff closure using barbed sutures<br>* 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 )<br>|
| Active Comparator: Vaginal cuff closure using conventional sutures<br>Vaginal cuff is closed with conventional sutures | Device: Vaginal cuff closure using conventional sutures<br>* Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suturing time of vaginal cuff |  | During hysterectomy operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | During hysterectomy operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Barbed sutures, Hysterectomy