Vaginal Cuff Dehiscence and Thermal Injury During TLH

Vaginal Cuff Dehiscence and Thermal Injury at the Time of Total Laparoscopic Hysterectomy: A Review of the Duke Experience and Randomized Controlled Trial

Purpose of this randomized control study is to determine if the mode of electrothermal colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or standard cut/coag form of electrothermal energy.

Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be used to examine the association fo dehiscence with proposed risk factors in the retrospective part of the study. In the randomized controlled trial, depth of thermal injury will be compared between the two groups, and a chi-square test will be used to test for a difference in clinical outcomes between the two groups. There is little risk associated with this study above the normal surgical risks; however, the V mode has not been previously been studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but all samples will be de-identified and given a unique study number, and only individuals directly involved in the study will be given access to the study information.

Study Overview

• Status: Completed
• Conditions: Thermal Injury; Vaginal Cuff Dehiscence
• Intervention / Treatment: Procedure: Cut-Coag; Device: Valleylab G3000 Electrosurgical Device; Procedure: V-mode

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥18 years
2. Patient scheduled for total laparoscopic hysterectomy (TLH)
3. Signed informed consent

Exclusion Criteria:

1. Known pelvic infection within 30 days prior to hysterectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cut/Coag	Procedure: Cut-Coag; Incision using electrothermal cautery, with an attempt made to use the "cut" (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the "coag" (pulsed high-voltage, low-current) mode.; Other Names: Valleylab G3000 Electrosurgical Device; Device: Valleylab G3000 Electrosurgical Device; Use of surgical device Valleylab G3000 Electrosurgical Device
Experimental: V-mode	Device: Valleylab G3000 Electrosurgical Device; Use of surgical device Valleylab G3000 Electrosurgical Device; Procedure: V-mode; Incision using electrothermal cautery in the "V mode". The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.; Other Names: Valleylab G3000 Electrosurgical Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy	distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing	a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection	4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Paula S Lee, MD, Duke University

Publications and helpful links

General Publications

• Teoh D, Lowery WJ, Jiang X, Ehrisman J, Halvorson P, Broadwater G, Bentley R, Secord AA, Sobolewski C, Berchuck A, Havrilesky LJ, Valea FA, Lee PS. Vaginal cuff thermal injury by mode of colpotomy at total laparoscopic hysterectomy: a randomized clinical trial. J Minim Invasive Gynecol. 2015 Feb;22(2):227-33. doi: 10.1016/j.jmig.2014.10.002. Epub 2014 Oct 8.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Total laparoscopic hysterectomy; Vaginal cuff dehiscence; Thermal Injury
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: Pro00019452