Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedDecember 20, 2016
December 1, 2016
1.8 years
December 16, 2016
December 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Suturing time of vaginal cuff
During hysterectomy operation
Secondary Outcomes (1)
Operative time
During hysterectomy operation
Study Arms (2)
Vaginal cuff closure using barbed sutures
EXPERIMENTALVaginal cuff is closed with barbed sutures
Vaginal cuff closure using conventional sutures
ACTIVE COMPARATORVaginal cuff is closed with conventional sutures
Interventions
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 will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .
Eligibility Criteria
You may qualify if:
- Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)
You may not qualify if:
- Genital malignancy
- Uterine size more than 16 weeks
- Coagulation defects or concurrent anticoagulant therapy
- Pregnancy
- Compromised cardiopulmonary status
- Contraindications for general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university
Qina, Egypt
Related 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. Epub 2013 May 14.
PMID: 23680517BACKGROUND
Study Officials
- 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
Central Study Contacts
Khaled A Elsetohy,, Prof.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
December 16, 2016
First Posted
December 20, 2016
Study Start
February 1, 2017
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
December 20, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share