Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Disease (or Disorder); Gynecological
• Intervention / Treatment: Device: Unidirectional Barbed Suture (V-Loc); Device: polyglactin 910 (Vicryl)

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • The West Clinic
    • Memphis, Tennessee, United States, 38103
      • Methodist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V-Loc Vaginal Cuff Closure; 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); Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.; Other Names: V-Loc Wound Closure System
Active Comparator: Vicryl Vaginal Cuff Closure; 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); Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.; Other Names: Vicryl

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: Methodist LeBonheur Hospital System; The West Clinic
• Investigators: Principal Investigator: Todd Tillmanns, MD, University of Tennessee, The West Clinic; Principal Investigator: Adam Mabe, MD, University of Tennessee

Publications and helpful links

General Publications

• Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.
• Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.
• Bradshaw AD, Advincula AP. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Dec;114(6):1372. doi: 10.1097/AOG.0b013e3181c3f60f. No abstract available.
• Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.

Helpful Links

• V-Loc Wound Closure Device Device Information

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: March 16, 2013
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimate): March 20, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 25, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: suture; hysterectomy; robotic; vaginal; cuff; vloc; v-loc; vicryl; unidirectional; barbed
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 11-01423-FB; 12-14 (Other Identifier: Baptist HealthCare IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No