CompletedNot Applicable

Vaginal Cuff Dehiscence and Thermal Injury During TLH

120 participantsStarted 2009-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 years
. Patient scheduled for total laparoscopic hysterectomy (TLH)
. Signed informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy

Timeframe: up to 36 months

Trial details

NCT IDNCT02080546

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2016-01-22

View on ClinicalTrials.gov More Vaginal Cuff Dehiscence trials

Plain-language summary