Vaginal Cuff Dehiscence and Thermal Injury During TLH

Study Overview
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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.

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

Conditions
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Vaginal Cuff Dehiscence, Thermal Injury

Intervention / Treatment
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* Procedure: Cut-Coag
* Procedure: V-mode
* Device: Valleylab G3000 Electrosurgical Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patient scheduled for total laparoscopic hysterectomy (TLH) Signed informed consent Exclusion Criteria: 1. Known pelvic infection within 30 days prior to hysterectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cut/Coag<br> | Procedure: Cut-Coag<br>* 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.<br>* Other names: Valleylab G3000 Electrosurgical Device;Device: Valleylab G3000 Electrosurgical Device<br>* Use of surgical device Valleylab G3000 Electrosurgical Device<br>|
| Experimental: V-mode<br> | Procedure: V-mode<br>* 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.<br>* Other names: Valleylab G3000 Electrosurgical Device;Device: Valleylab G3000 Electrosurgical Device<br>* Use of surgical device Valleylab G3000 Electrosurgical Device<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal cuff dehiscence, Thermal Injury, Total laparoscopic hysterectomy