Clinical trial NCT01814579: Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy
Official title: Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disease (or Disorder); Gynecological
Keywords: vaginal
cuff
robotic
hysterectomy
vloc
v-loc
vicryl
unidirectional
barbed
suture
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Methodist LeBonheur Hospital System
name: The West Clinic
First posted: 2013-03-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal Cuff Closure Time
timeFrame: At time of surgery
Secondary outcomes:
measure: Vaginal Cuff Dehiscence
timeFrame: Post Operatively (3 months)
measure: Vaginal Cuff Evisceration
timeFrame: Post Operatively (3 months)
measure: Vaginal Cuff Granulation Tissue Formation
timeFrame: Post Operatively (3 months)
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
affiliation: University of Tennessee, The West Clinic
name: Todd Tillmanns, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Adam Mabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.