Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

Study Overview
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Brief Summary
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This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.

Detailed Description
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Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.

Official Title
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Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy, a Randomized Controlled Trial

Conditions
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Disease (or Disorder); Gynecological

Intervention / Treatment
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* Device: Unidirectional Barbed Suture (V-Loc)
* Device: polyglactin 910 (Vicryl)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians Females age 18+ Exclusion Criteria: Patients receiving ongoing radiation therapy to the pelvis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-Loc Vaginal Cuff Closure<br>Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy. | Device: Unidirectional Barbed Suture (V-Loc)<br>* Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.<br>* Other names: V-Loc Wound Closure System;|
| Active Comparator: Vicryl Vaginal Cuff Closure<br>Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy. | Device: polyglactin 910 (Vicryl)<br>* Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.<br>* Other names: Vicryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Cuff Closure Time | Vaginal cuff closure time will be timed at time of robotic hysterectomy. | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Cuff Dehiscence | Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff dehiscence has occurred and will be again screened by phone 3 months post operatively. | Post Operatively (3 months) | 
| Vaginal Cuff Evisceration | Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff evisceration has occurred and will be again screened by phone 3 months post operatively. | Post Operatively (3 months) | 
| Vaginal Cuff Granulation Tissue Formation | Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff granulation tissue formation has occurred and will be again screened by phone 3 months post operatively. | Post Operatively (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal, cuff, robotic, hysterectomy, vloc, v-loc, vicryl, unidirectional, barbed, suture