Vaginal Cuff Dehiscence and Thermal Injury During TLH

Thermal Injury Clinical Trial

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

Status Completed

Clinical Trial Summary

Purpose of the study Part 1: Retrospective Review: The purpose of part 1 is to establish the historical rate of vaginal cuff dehiscence following total laparoscopic hysterectomy compared to total abdominal hysterectomy (TAH), total vaginal hysterectomy (TVH), radical hysterectomy (RH) and laparoscopic-assisted vaginal hysterectomy (LAVH) at Duke University Medical Center.

Part 2: Prospective Randomized Controlled Trial: The purpose of part 2 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thermal Injury
• Vaginal Cuff Dehiscence

• NCT number: NCT02080546
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: December 2009