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Robot or scalpel? new trial tests safer surgery for endometriosis sufferers

NCT ID NCT06445179

Symptom relief Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares robot-assisted hysterectomy to standard laparoscopic surgery for women with deep endometriosis and adenomyosis. The goal is to see which approach leads to fewer complications and better quality of life. 224 participants will be randomly assigned to one of the two procedures, and outcomes like complication rates, pain, and sexual function will be tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Total Laparoscopic Hysterectomy (procedure)
What this could lead to
If robot-assisted surgery proves safer, it could become the preferred method for hysterectomy in severe endometriosis, reducing complications and improving recovery.
What could go wrong
This is a mid-stage trial with 224 participants, so results may not apply to all patients. Robot-assisted surgery is not yet proven superior, and it may be more expensive or slower without clear benefit.

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

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

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 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * ≥ 18 years of age. * Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) per the Enzian and dPEI classifications. * Diagnosed deep infiltrating endometriosis per the Enzian and dPEI classifications, without the involvement of the digestive tract. * Failure of first- and second-line medical treatment. * Eligibility for total hysterectomy with complete removal of endometriosis lesions. * Participants covered by entitled to social security. * All participants must provide written informed consent before undergoing the surgical procedure. Exclusion Criteria: * Digestive tract involvement. * Adenomyosis only. * Contraindications to surgery. * Participants who are under guardianship, curatorship, or deprivation of liberty.

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Conditions

The condition(s) this trial relates to.

adenomyosis endometriosis

As listed by the trial registrant

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

Endometriosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hôpital Privé de Provence

    RECRUITING

    Aix-en-Provence, 13080, France

  • Hôpital Privé le Bois

    RECRUITING

    Lille, 59000, France

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