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Clinical Trials/NCT02998658
NCT02998658
Unknown
Phase 2

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

Cairo University1 site in 1 country54 target enrollmentStarted: February 2017Last updated:
ConditionsHysterectomy

Overview

Phase
Phase 2
Enrollment
54
Locations
1
Primary Endpoint
Suturing time of vaginal cuff

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Suturing time of vaginal cuff

Time Frame: During hysterectomy operation

Secondary Outcomes

  • Operative time(During hysterectomy operation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Usama M Fouda

Prof.

Cairo University

Study Sites (1)

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