Battle of the scarless surgeries: which hysterectomy technique wins?
NCT ID NCT06663553
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares two advanced, minimally invasive hysterectomy techniques—TU-LESS (through the belly button) and vNOTES (through the vagina)—in 210 women with an enlarged uterus. The goal is to see which method leads to faster recovery, less pain, and shorter hospital stays. Participants will be randomly assigned to one of the two procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could show which surgical method leads to faster recovery and less discomfort for women with an enlarged uterus needing hysterectomy.
- What could go wrong
- This is a small, early-stage comparative study, not a large confirmatory trial. Results may not apply to all patients, and individual outcomes can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Eligible women aged 18-70 years. * Women with indications for enlarged uterine volumes who are planning to under go total hysterectomy. Uterine size should exceed that of a 3-month pregnancy (uterine weight ≥ 280 g). * Patients are willing to be randomly assigned to undergo any of both approaches. * Patients who are willing to sign the informed consent form. Exclusion Criteria: * Individuals who are virgins or have vaginal stenosis. * Patients requiring concurrent surgical intervention for conditions such as ovarian cysts or lesions of the vulva, vagina, appendix, etc. * presence of uterus exceeding approximately 20 gestational weeks in size (about 900-1000g), which is beyond the limitations of a single-site laparoscopic approach due to concerns regarding technical feasibility and safety * Presence of malignancy or strong suspicion of malignancy that may alter the planned surgical approach. * History of two or more pelvic surgeries or suspected severe pelvic adhesions (rectovaginal examination suggesting rectovaginal endometriosis or limited uterine mobility). * History of peritoneal dialysis, pelvic radiation therapy and pelvic tuberculosis treated with laparoscopic surgery. * Patients with prolapse or pelvic inflammation. * Diabetes mellitus with poor blood glucose control. * Body mass index greater than 30 kg/m².
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Second University Hospital
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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