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Could less gas in the belly mean less pain after pelvic surgery?

NCT ID NCT04858438

Symptom relief Sponsor: Henry Ford Health System 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial asks whether using a lower gas pressure to inflate the abdomen during robotic-assisted sacrocolpopexy (a surgery to fix pelvic organ prolapse) can reduce pain after the operation. Adults aged 18 to 90 scheduled for this surgery may join. Researchers will measure pain levels and painkiller use during the first day and at two weeks after surgery, and also check safety by tracking operation time, blood loss, and any need to increase pressure.

What this could mean

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

Active substance
Insufflation during surgery (the gas used to inflate the abdomen during robotic-assisted sacrocolpopexy)
What this could lead to
If lower gas pressure works, it could lead to less pain and less need for painkillers after pelvic prolapse surgery, improving recovery.
What could go wrong
This is a small, early-stage trial, and lower pressure might not reduce pain or could make surgery harder or less safe. Results may not apply to all patients.

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.

Started

Apr 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 90 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: * Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse. * Age 18-90 years * Can read and understand the consent form and consents to the procedure Exclusion Criteria: * Patients undergoing other procedures * Patients who do not consent to participate.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative pelvic organ prolapse Pneumoperitoneum

As listed by the trial registrant

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

Pelvic organ prolapse

Contacts and locations

Locations

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.