Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy
NCT ID: NCT02998658
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2017-02-28
2019-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vaginal cuff closure using barbed sutures
Vaginal cuff is closed with barbed sutures
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 is closed with conventional sutures
Vaginal cuff closure using conventional sutures
Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .
Interventions
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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) .
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Uterine size more than 16 weeks
* Coagulation defects or concurrent anticoagulant therapy
* Pregnancy
* Compromised cardiopulmonary status
* Contraindications for general anesthesia
30 Years
70 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Usama M Fouda
Prof.
Principal Investigators
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Usama M Fouda, Prof.
Role: STUDY_DIRECTOR
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Khaled A Elsetohy,, Prof.
Role: PRINCIPAL_INVESTIGATOR
Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
Locations
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Cairo university
Qina, , Egypt
Countries
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Central Contacts
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Khaled A Elsetohy,, Prof.
Role: CONTACT
Facility Contacts
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Usama M. Fouda, Prof.
Role: primary
References
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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.
Other Identifiers
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Barbed/vaginal cuff
Identifier Type: -
Identifier Source: org_study_id