Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Pelvic Organ Prolapse Clinical Trial

Official title:

Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858438
• Other study ID #: 1716019
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Ascension South East Michigan
• Contact: Gabriella Rustia, MD
• Phone: 313-343-6708
• Email: gabriella.rustia[@]ascension.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Insufflation during surgery
This is the amount of insufflation using during the surgical procedure.

Locations

Country	Name	City	State
United States	Ascension St. John Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pain will be assessed within 24 hours of the surgery. .
Primary	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.	Pain will be assessed at the two-week post-operative follow-up visit.
Primary	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.	Safety will be assessed during the procedure.
Primary	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.	Safety will be assessed immediately post-operatively.
Primary	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.	Safety will be assessed at the two-week follow-up visit.