Vaginal Cuff Closure in Robotic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of implementing different types of suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic hysterectomy on cost, operative time and post operative surgical outcomes.

Detailed Description
-----------------
Robotic assisted laparoscopic surgery is the fastest growing new modality in gynecologic surgery. Surgeons are adapting it to perform both benign and oncologic gynecologic procedures. Therefore, the fastest growing robotic procedure in the united states is hysterectomy. The literature in laparoscopic hysterectomy, both robotic and non-robotic, reports a complication of vaginal closure disruption after hysterectomy higher than with abdominal surgery. Reasons hypothesized for this phenomenon include colpotomy (vaginal incision) technique, vaginal closure technique, and types of suture. At present, no further follow up studies have been done to test some of these hypothesis. In light of the rapid adoption of this approach to hysterectomy, more data on this issue will help the physician in counseling patients regarding complications, as well as helping surgeons choose materials and techniques in their hysterectomies which will diminish the chance for this unfortunate complication, which causes pain, hospitalization and excess morbidity after the original surgery. Additionally, a parallel development of newer suturing materials, the so-called barbed self-anchoring sutures, typically fabricated from monofilament materials, have been reported used in laparoscopic hysterectomies in case series. The relative contribution of theses newer materials to the rates of cuff disruption is unknown. The protocol proposes testing the null hypothesis that different suture materials and methods of closure do not cause a significant difference in the rates of vaginal cuff disruption after robotic assisted laparoscopic total hysterectomy. Study design is a prospective randomized controlled trial. Patients will be blindly randomized to one of the 3 closure techniques using 3 different materials. Technique and material by necessity can not be blinded to the surgeon. Otherwise, standard surgical technique will be used. Followup in 2 and 6 weeks for clinical assessment will be performed. To asses the long term of cuff disruption, a 12 month interview will be also conducted. Data points will include operative time for closure, postoperative pain at 2 and 6 weeks, postoperative pain with urination/voiding at 2 and 6 weeks, spotting, bleeding and /or frank vaginal disruption documented at 2 and 6 weeks, and pain and presence of dyspareunia at 12 months will be assessed. Cost associated with cuff closure will be calculated by addition of OR time and material cost.

Official Title
-----------------
Vaginal Cuff Closure in Robotic Hysterectomy

Conditions
-----------------
Complications of Medical Care

Intervention / Treatment
-----------------
* Device: V-lock suture
* Device: Vicryl Suture
* Device: Lapra-Ty II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women scheduled for robotic assisted laparoscopic hysterectomy Exclusion Criteria: Patients who will not consent. Hysterectomy due to malignant conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: V-lock suture<br>V-lock absorbable Wound Closure Device, by Covidien | Device: V-lock suture<br> <br> |
| Active Comparator: Vicryl suture<br>Vicryl suture by Ethicon | Device: Vicryl Suture<br> <br> |
| Active Comparator: Lapra-Ty II<br>Lapra-Ty II, Absorbable Suture Clip, by Ethicon | Device: Lapra-Ty II<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal cuff dehiscence | Postoperative inspection for vaginal cuff dehiscence | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Post-operative vaginal bleeding, bowel or urinary dysfunction | 6 weeks | 
| Operative time costs | Measurement of operative time and determination of unit cost per surgery | 1 year | 
| Suturing material costs | Comparison of the amount and type of suture utilized per surgery | 1 year | 
| Operative suturing time | Time to complete Vaginal cuff closure | During surgery | 
| Post operative pain | Visual Analog Scale | 6 weeks | 
| Vaginal bleeding/ spotting | Presence of postoperative vaginal bleeding | 12 months | 
| Resumption of sexual activity | Time to resumption of intercourse | 12 months | 
| Dyspareunia | Assessment of Painful Intercourse | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal cuff closure, Robotic Hysterectomy