Vaginal Cuff Dehiscence and Thermal Injury During TLH

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginal Cuff Dehiscence Thermal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cut/Coag

Group Type ACTIVE_COMPARATOR

Cut-Coag

Intervention Type PROCEDURE

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.

Valleylab G3000 Electrosurgical Device

Intervention Type DEVICE

Use of surgical device Valleylab G3000 Electrosurgical Device

V-mode

Group Type EXPERIMENTAL

V-mode

Intervention Type PROCEDURE

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.

Valleylab G3000 Electrosurgical Device

Intervention Type DEVICE

Use of surgical device Valleylab G3000 Electrosurgical Device

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE