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Vaginal Cuff Dehiscence and Thermal Injury During TLH

NCT02080546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-06-03

Study results available
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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.

Conditions

  • Vaginal Cuff Dehiscence
  • Thermal Injury

Interventions

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.

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.

DEVICE

Valleylab G3000 Electrosurgical Device

Use of surgical device Valleylab G3000 Electrosurgical Device

Sponsors & Collaborators

Principal Investigators

  • Paula S Lee, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080546 on ClinicalTrials.gov