Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Sponsor

Ascension South East Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04858438

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Insufflation during surgery	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).

Masking:

Single (Participant)

Masking Description:

Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.

Primary Purpose:

Treatment

Official Title:

Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Actual Study Start Date :

Apr 2, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Insufflation Group Patients will receive standard insufflation during surgery (15 mm Hg).	Procedure: Insufflation during surgery This is the amount of insufflation using during the surgical procedure.
Experimental: Low Insufflation Group Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).	Procedure: Insufflation during surgery This is the amount of insufflation using during the surgical procedure.

Arm

Intervention/Treatment

Active Comparator: Standard Insufflation Group

Patients will receive standard insufflation during surgery (15 mm Hg).

Procedure: Insufflation during surgery

This is the amount of insufflation using during the surgical procedure.

Experimental: Low Insufflation Group

Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).

Procedure: Insufflation during surgery

This is the amount of insufflation using during the surgical procedure.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ascension St. John Hospital	Detroit	Michigan	United States	48236

Sponsors and Collaborators

Ascension South East Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ascension South East Michigan

ClinicalTrials.gov Identifier:

NCT04858438

Other Study ID Numbers:

1716019

First Posted:

Apr 26, 2021

Last Update Posted:

Apr 27, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ascension South East Michigan

Sacrocolpopexy

Pneumoperitoneum

Postoperative pain

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Apr 27, 2021