Vaginal Cuff Closure in Robotic Hysterectomy

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.

Study Overview

• Status: Completed
• Conditions: Complications of Medical Care
• Intervention / Treatment: Device: V-lock suture; Device: Vicryl Suture; Device: Lapra-Ty II

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women scheduled for robotic assisted laparoscopic hysterectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

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
Operative suturing time	Time to complete Vaginal cuff closure	During surgery
Post operative pain	Visual Analog Scale	6 weeks
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
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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: David Eisenstein, MD, Henry Ford Health System

Publications and helpful links

General Publications

• AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available.
• Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 21, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimated): March 2, 2016

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: vaginal cuff closure; Robotic Hysterectomy
• Other Study ID Numbers: 6297 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No