Vaginal Cuff Closure in Robotic Hysterectomy

Not Applicable

Completed

• Conditions: Complications of Medical Care
• Interventions: Device: Vicryl Suture; Device: V-lock suture; Device: Lapra-Ty II

• Registration Number: NCT02696239
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-21
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-02
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Women scheduled for robotic assisted laparoscopic hysterectomy

Exclusion Criteria

• Patients who will not consent.
• Hysterectomy due to malignant conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vicryl suture	Vicryl Suture	Vicryl suture by Ethicon
V-lock suture	V-lock suture	V-lock absorbable Wound Closure Device, by Covidien
Lapra-Ty II	Lapra-Ty II	Lapra-Ty II, Absorbable Suture Clip, by Ethicon

Primary Outcome Measures

Name	Time	Method
Vaginal cuff dehiscence	12 months	Postoperative inspection for vaginal cuff dehiscence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States