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

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02998658
• Other study ID #: Barbed/vaginal cuff
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 16, 2016
• Last updated: December 19, 2016
• Start date: February 2017
• Est. completion date: February 2019

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: Usama M Fouda, Prof.
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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 )
• Vaginal cuff closure using conventional sutures
Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .

Locations

Country	Name	City	State
Egypt	Cairo university	Caene

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suturing time of vaginal cuff		During hysterectomy operation	No
Secondary	Operative time		During hysterectomy operation	No