Vaginal Cuff Dehiscence and Thermal Injury During TLH

Not Applicable

Completed

• Conditions: Vaginal Cuff Dehiscence; Thermal Injury
• Interventions: Procedure: V-mode; Procedure: Cut-Coag; Device: Valleylab G3000 Electrosurgical Device

• Registration Number: NCT02080546
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2014-02
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Status Verified: 2016-01
• Results First Submitted: 2016-01-22
• Results First Submitted QC: 2016-04-28
• Last Update Submitted: 2016-04-28
• Results First Posted: 2016-06-03
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Read More

Exclusion Criteria

1. Known pelvic infection within 30 days prior to hysterectomy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V-mode	V-mode	-
Cut/Coag	Cut-Coag	-
Cut/Coag	Valleylab G3000 Electrosurgical Device	-
V-mode	Valleylab G3000 Electrosurgical Device	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing	4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination	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