CompletedNot Applicable

Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

South Korea40 participantsStarted 2016-04

Plain-language summary

The aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.

Who can participate

Age range

19 Years – 75 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: * women with gynecologic diseases, such as uterine myoma, adenomyosis, and ovarian tumor; * women who were planning to undergo TLH; * women between 19 and 75 years of age. Exclusion Criteria: * women with any suggestion of malignant cervical or vaginal pathologies * women with uncontrolled medical comorbidities or psychiatric illness, which could affect follow-up and/or compliance * women who refused to participate or give consent to the procedures.

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 surgical smoke obstructing vision

Timeframe: Day of surgery

Degree of lateral thermal damage

Timeframe: Day of surgery

Trial details

NCT IDNCT02729272

SponsorKangbuk Samsung Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04

View on ClinicalTrials.gov More Gynecologic Diseases trials