Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy
NCT ID: NCT02293369
Last Updated: 2016-01-08
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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COMPLETED
NA
58 participants
INTERVENTIONAL
2014-11-30
2015-11-30
Brief Summary
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Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.
Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cuff closure via vaginal route
For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite and will continue toward the surgeon until the other uterosacral ligament will be incorporated into the repair, using a continuous 0-Vicryl suture in the vaginal route.
Cuff closure via vaginal route
Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
Cuff closure via laparoscopic route
For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. In the laparoscopic approach, needles will be introduced through the umbilical trocar and removed through the peripheral trocars and intracorporeal knots will be utilized.
Cuff closure via laparoscopic route
Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.
Interventions
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Cuff closure via vaginal route
Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
Cuff closure via laparoscopic route
Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of large adnexal masses (maximum diameter \>10 cm at preoperative ultrasonography)
FEMALE
No
Sponsors
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University of Surrey
OTHER
Istanbul University
OTHER
Responsible Party
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Ercan Bastu
Associate Professor of Obstetrics and Gynecology
Principal Investigators
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Faruk Buyru, M.D.
Role: STUDY_CHAIR
Istanbul University School of Medicine
Locations
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Department of Obstetrics and Gynecology, Istanbul University School of Medicine
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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1424
Identifier Type: -
Identifier Source: org_study_id
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