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Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insufflation during surgery
Sponsored by
Ascension South East Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Sacrocolpopexy, Pneumoperitoneum, Postoperative pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ascension St. John HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Insufflation Group

Low Insufflation Group

Arm Description

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

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

Outcomes

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 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 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.
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.
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.
The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2021
Last Updated
April 23, 2021
Sponsor
Ascension South East Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04858438
Brief Title
Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
Official Title
Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascension South East Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Sacrocolpopexy, Pneumoperitoneum, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive either standard pneumoperitoneum (15 mmHg) versus a lower level of pneumoperitoneum (12 mmHg).
Masking
Participant
Masking Description
Patients will be unaware of their study group status and unaware of level of pneumoperitoneum used during their surgical procedure.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Insufflation Group
Arm Type
Active Comparator
Arm Description
Patients will receive standard insufflation during surgery (15 mm Hg).
Arm Title
Low Insufflation Group
Arm Type
Experimental
Arm Description
Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).
Intervention Type
Procedure
Intervention Name(s)
Insufflation during surgery
Intervention Description
This is the amount of insufflation using during the surgical procedure.
Primary Outcome Measure Information:
Title
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Description
Pain will be assessed during the 24-hour post-operative period.
Time Frame
Pain will be assessed within 24 hours of the surgery. .
Title
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Description
Pain will be assessed during the two-week post-operative period.
Time Frame
Pain will be assessed at the two-week post-operative follow-up visit.
Title
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
Description
The safety of the lower insufflation pressure will be assessed during the procedure.
Time Frame
Safety will be assessed during the procedure.
Title
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
Description
The safety of the lower insufflation pressure will be assessed immediately post-operatively.
Time Frame
Safety will be assessed immediately post-operatively.
Title
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.
Description
The safety of the lower insufflation pressure will be assessed at the two-week follow-up visit.
Time Frame
Safety will be assessed at the two-week follow-up visit.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This procedure only applies to women.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriella Rustia, MD
Phone
313-343-6708
Email
gabriella.rustia@ascension.org
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad F Aslam, MD
Phone
313-343-3494
Email
muhammad.aslam@ascension.org
Facility Information:
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella M Rustia, MD
Email
gabriella.rustia@ascension.org
First Name & Middle Initial & Last Name & Degree
Muhammad F Aslam, MD
Email
muhammad.aslam@ascension.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

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