Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

University of Tennessee80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Disease (or Disorder); Gynecological

Interventions

Unidirectional Barbed Suture (V-Loc)DEVICE

Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.

polyglactin 910 (Vicryl)DEVICE

Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Methodist University Hospital

Memphis, Tennessee, United States

The West Clinic

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Vaginal Cuff Closure Time

Vaginal cuff closure time will be timed at time of robotic hysterectomy.

Time frame: At time of surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Post Operatively (3 months)

Data from ClinicalTrials.gov

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