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Newer vaginal surgery for hysterectomy may be as safe as standard keyhole method

NCT ID NCT05031182

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two surgical techniques for removing the uterus (hysterectomy) due to non-cancerous conditions: the newer vNOTES method (done through the vagina) and standard laparoscopy (keyhole surgery). 145 women took part, and researchers tracked complications, pain, and recovery for six months after surgery. The goal was to see if vNOTES is as safe and well-tolerated as the traditional laparoscopic approach.

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

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

145 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 2025

Lead sponsor

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

18 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy. * Able to give informed consent to participate in research. * Affiliation to a Social Security scheme. Exclusion Criteria: * Pregnant or breastfeeding women * Contraindication to the laparoscopic approach * Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection * Indications for another concomitant surgical procedure (other than procedure on the appendix) * Indication of hysterectomy for malignant lesion. * Any concomitant pathology deemed incompatible with the study. * COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery. * Adult patient protected, under guardianship or curatorship or legal safeguard * Refusal of participation.

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Conditions

The condition(s) this trial relates to.

uterine benign neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hysterectomy Laparoscopy VNOTES

Contacts and locations

Locations

  • CH d'Issoire

    Issoire, France

  • CHU clermont-ferrand

    Clermont-Ferrand, France

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