Pelvic Organ ProlapseNCT04858438
Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
A study testing Insufflation during surgery in people with Pelvic Organ Prolapse, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Insufflation during surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing other procedures
- Patients who do not consent to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension St. John Hospital
Detroit, Michigan, 48236
About this study
This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.
Read the detailed description
This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine \& Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Insufflation during surgery
- Keywords
- Sacrocolpopexy, Pneumoperitoneum, Postoperative pain
- Medical subject headings
- Pelvic Organ Prolapse, Pneumoperitoneum, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insufflation during surgeryProcedure or surgery
This is the amount of insufflation using during the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard Insufflation Group | Active comparator | Patients will receive standard insufflation during surgery (15 mm Hg). Receives: Procedure: Insufflation during surgery |
| Low Insufflation Group | Experimental | Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower). Receives: Procedure: Insufflation during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Pain will be assessed during the 24-hour post-operative period.
Measured: 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.
Pain will be assessed during the two-week post-operative period.
Measured: 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.
The safety of the lower insufflation pressure will be assessed during the procedure.
Measured: 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.
The safety of the lower insufflation pressure will be assessed immediately post-operatively.
Measured: 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.
The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.
Measured: Safety will be assessed at the two-week follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start2 Apr 2021
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Why it stopped: Joint venture occurred and PI did not continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858438
- Sponsor's protocol ID
- 1716019
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2021
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rustia GM, Baracy MG Jr, Khair E, Hagglund KH, Aslam MF. Pain With Differing Insufflation Pressures During Robotic Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7.
PubMed 37348093
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
- ClinicalTrials.gov ID
- NCT04858438
- Acronym / sponsor ID
- 1716019
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Sacrocolpopexy, Pneumoperitoneum, Postoperative pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Joint venture occurred and PI did not continue study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.
Detailed description
This is a prospective single-blind randomized controlled trial of adult women undergoing robotic-assisted sacrocolpopexy for pelvic organ prolapse. Each surgery will be performed by a board-certified Female Pelvic Medicine \& Reconstructive Surgery (FPMRS) surgeon with a standard technique other than pneumoperitoneum level. A sacrocolpopexy for apical prolapse may be performed at the same time as a hysterectomy and other clinically indicated procedures if desired by the patient and as part of the standard of care. Patients will be stratified by hysterectomy prior to randomization. Postoperatively, patients will be evaluated with a Visual Analogue Scale (VAS) as well as prescribed narcotic analgesic use and followed up to 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
| Arm | Type | Receives |
|---|---|---|
| Standard Insufflation Group | Active comparator | Procedure: Insufflation during surgeryPatients will receive standard insufflation during surgery (15 mm Hg). |
| Low Insufflation Group | Experimental | Procedure: Insufflation during surgeryPatients will receive a lower level of insufflation during surgery (12 mm Hg or lower). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients undergoing other procedures
- Patients who do not consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insufflation during surgeryThis is the amount of insufflation using during the surgical procedure. | Procedure or surgery | Low Insufflation Group, Standard Insufflation Group |
Primary outcome
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Time frame: Pain will be assessed within 24 hours of the surgery. .
Pain will be assessed during the 24-hour post-operative period.
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Time frame: Pain will be assessed at the two-week post-operative follow-up visit.
Pain will be assessed during the two-week post-operative period.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
Time frame: Safety will be assessed during the procedure.
The safety of the lower insufflation pressure 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.
Time frame: Safety will be assessed immediately post-operatively.
The safety of the lower insufflation pressure 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.
Time frame: Safety will be assessed at the two-week follow-up visit.
The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 37348093Rustia GM, Baracy MG Jr, Khair E, Hagglund KH, Aslam MF. Pain With Differing Insufflation Pressures During Robotic Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insufflation during surgery in people with Pelvic Organ Prolapse, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain. (time frame: Pain will be assessed within 24 hours of the surgery. .). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.