Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

Disease (or Disorder); Gynecological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01814579
• Other study ID #: 11-01423-FB
• Secondary ID: 12-14
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 16, 2013
• Last updated: March 25, 2013
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2013
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Disease (or Disorder); Gynecological

Intervention

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.
• polyglactin 910 (Vicryl)
Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.

Locations

Country	Name	City	State
United States	Methodist University Hospital	Memphis	Tennessee
United States	The West Clinic	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Tennessee	Methodist LeBonheur Hospital System, The West Clinic

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bradshaw AD, Advincula AP. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Dec;114(6):1372; author reply 1372-3. doi: 10.1097/AOG.0b013e3181c3f60f. — View Citation

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. — View Citation

Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal Cuff Closure Time	Vaginal cuff closure time will be timed at time of robotic hysterectomy.	At time of surgery	No
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	No

External Links

•   V-Loc Wound Closure Device Device Information