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Robot vs. surgeon: which surgery is safer for pelvic organ prolapse?

NCT ID NCT01320215

Disease control Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two types of minimally invasive surgery for pelvic organ prolapse in 365 women. One group had robot-assisted surgery, while the other had standard laparoscopic surgery without a robot. The main goal was to see which approach had fewer complications within 30 days after the operation.

What this could mean

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

Active substance
robot-assisted or non-robot laparoscopic surgery
What this could lead to
If robot-assisted surgery proves safer, it could become the preferred option for pelvic organ prolapse repair, reducing complications and improving recovery.
What could go wrong
This is a completed trial comparing two surgical techniques, not a new treatment. Results may show no significant difference, and individual outcomes vary based on surgeon skill and patient factors.

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

365 people

The number who actually took part.

Started

Jun 2011

Finished

Jan 2022

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: * Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery * The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 60 months of follow-up Exclusion Criteria: * The patient is participating in another study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant * Patient has a stage-1 prolapse (POP-Q classification) * Patient has asymptomatic prolapse * The patient has a prolapse recurrence (i.e. this is not the first case of prolapse) * The patient is not available for 60 months of follow-up * Patient has a vaginal or urinary infection * Patient has poorly-adjusted diabetes * Patient on long-term corticotherapy * Patient has previously had pelvic radiotherapy * Patient has contraindication for anesthesia * Patient has an intestinal inflammatory disease

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse Uterine Prolapse

As listed by the trial registrant

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

Pelvic organ prolapse

Contacts and locations

Locations

  • APHP - Centre Hospitalier Henri Mondor

    Créteil, 94000, France

  • APHP - Groupe Hospitalier Pitié-Salpetrière

    Paris, 75651, France

  • CHRU de Strasbourg - Hôpital Civil

    Strasbourg, 67091, France

  • CHRU de Toulouse - Hôpital de Rangueil

    Toulouse, 31059, France

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37044, France

  • CHU de Dijon

    Dijon, 21079, France

  • CHU de Lyon - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295, France

  • CHU de Nancy - Hôpitaux de Brabois

    Nancy, France

  • CHU de Nantes

    Nantes, 44000, France

  • CHU de Nice - Hôpitaux L'Archet 1 et 2

    Nice, 06202, France

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard, 30029, France

  • CHU de Rennes - Hôpital PontChaillou

    Rennes, 35033, France

  • Clinique Belledonne

    Saint Martin d'Héres, 38400, France

  • Clinique Kennedy

    Nîmes, 30900, France

  • Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

    Paris, 75012, France

  • Groupe Urologie Saint Augustin

    Bordeaux, 33074, France

  • Hôpital Foch

    Suresnes, 92151, France

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