Vaginal Cuff Dehiscence and Thermal Injury During TLH
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About
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.
Enrollment
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Volunteers
Inclusion criteria
- Age ≥18 years
- Patient scheduled for total laparoscopic hysterectomy (TLH)
- Signed informed consent
Exclusion criteria
- Known pelvic infection within 30 days prior to hysterectomy
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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