Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

Not Applicable

• Conditions: Disease (or Disorder); Gynecological
• Interventions: Device: polyglactin 910 (Vicryl); Device: Unidirectional Barbed Suture (V-Loc)

• Registration Number: NCT01814579
• Lead Sponsor: University of Tennessee

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2012-07
• Status Verified: 2013-03
• Study First Submitted: 2013-03-16
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-20
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26
• Primary Completion: 2013-05
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vicryl Vaginal Cuff Closure	polyglactin 910 (Vicryl)	Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy.
V-Loc Vaginal Cuff Closure	Unidirectional Barbed Suture (V-Loc)	Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy.

Primary Outcome Measures

Name	Time	Method
Vaginal Cuff Closure Time	At time of surgery	Vaginal cuff closure time will be timed at time of robotic hysterectomy.

Secondary Outcome Measures

Name	Time	Method
Vaginal Cuff Dehiscence	Post Operatively (3 months)	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.
Vaginal Cuff Evisceration	Post Operatively (3 months)	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.
Vaginal Cuff Granulation Tissue Formation	Post Operatively (3 months)	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.

Trial Locations

Locations (2)

Methodist University Hospital; 🇺🇸 Memphis, Tennessee, United States

The West Clinic; 🇺🇸 Memphis, Tennessee, United States