Disease (or Disorder); Gynecological
Conditions
Keywords
vaginal, cuff, robotic, hysterectomy, vloc, v-loc, vicryl, unidirectional, barbed, suture
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.
Interventions
DEVICEUnidirectional 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.
DEVICEpolyglactin 910 (Vicryl)
Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.
Sponsors
Methodist LeBonheur Hospital System
The West Clinic
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Cuff Closure Time | At time of surgery | Vaginal cuff closure time will be timed at time of robotic hysterectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed