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Prolapse surgery without overnight stay? new study tests feasibility

NCT ID NCT03573752

Symptom relief Sponsor: University Hospital, Strasbourg, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether laparoscopic promontofixation, a common surgery for pelvic organ prolapse, can be safely performed as an outpatient procedure. Sixty women who needed the surgery were discharged 8 hours after the operation. The main goal was to see how many needed to be readmitted to the hospital. Patients also filled out questionnaires about their pain, anxiety, and overall satisfaction.

What this could mean

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

Active substance
outpatient management (early discharge after laparoscopic promontofixation)
What this could lead to
If successful, this could show that laparoscopic prolapse repair can be safely done as outpatient surgery, reducing hospital stays and healthcare costs.
What could go wrong
This is a small, single-center study with only 60 participants, so results may not apply broadly. Outpatient management may not be suitable for all patients, and there is a risk of complications requiring readmission.

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

60 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2021

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

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: * Woman with promontofixation indication by laparoscopy for prolapse cure * Patient's desire for outpatient management * Age ≥18 years and \<70 years * Absence of a major medical or surgical history that would prolong hospitalization (ASA 1 or 2, absence of Obstructive Sleep Apnea Syndrome) * Subject affiliated to a social security scheme * Subject having signed an informed consent * Availability of a caregiver, responsible and valid (for the first 48 hours after the potential early exit) at home * Geographical distance less than one hour from a suitable care facility * Access to a telephone or a means of transport if necessary * Patient compliance * Oral and written comprehension of pre- and post-operative instructions * Correct housing condition * Subject having been informed of the results of the prior medical examination Exclusion Criteria: * Laparoscopic contraindication * Comorbidity needs of medical supervision most of 24h * TVT-O procedure during the same surgery * Mental handicap affecting autonomy * Comprehension difficulties to understand the protocol * No social protection * Subject with curatorship or guardianship * Morbid obesity * Alcohol or drugs addiction * Excessive anxiety * Impossibility to give the subject enlightened information (subject in emergency situation...) * Pregnant woman (positive urinary pregnancy test for women of childbearing age)

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Conditions

The condition(s) this trial relates to.

pelvic organ 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

  • Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg

    Schiltigheim, 67303, France

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