WithdrawnNot Applicable

Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Stopped: Joint venture occurred and PI did not continue study.

United States0Started 2021-04-02

Plain-language summary

This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

Who can participate

Age range

18 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.

Timeframe: Pain will be assessed within 24 hours of the surgery. .

Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.

Timeframe: Pain will be assessed at the two-week post-operative follow-up visit.

Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Timeframe: Safety will be assessed during the procedure.

Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Timeframe: Safety will be assessed immediately post-operatively.

Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Timeframe: Safety will be assessed at the two-week follow-up visit.

Trial details

NCT IDNCT04858438

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-01

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials

Who can participate

Age range

18 Years – 90 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.

Timeframe: Pain will be assessed within 24 hours of the surgery. .

Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.

Timeframe: Pain will be assessed at the two-week post-operative follow-up visit.

Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Timeframe: Safety will be assessed during the procedure.

Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Timeframe: Safety will be assessed immediately post-operatively.

Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Timeframe: Safety will be assessed at the two-week follow-up visit.