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

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.

Study Overview

• Status: Unknown
• Conditions: Hysterectomy
• Intervention / Treatment: Device: Vaginal cuff closure using barbed sutures; Device: Vaginal cuff closure using conventional sutures

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

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Caene, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative time	During hysterectomy operation

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Usama M Fouda, Prof., Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department; Principal Investigator: Khaled A Elsetohy,, Prof., Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department

Publications and helpful links

General Publications

• Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Laparoscopy; Hysterectomy; Barbed sutures
• Other Study ID Numbers: Barbed/vaginal cuff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No