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Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

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ClinicalTrials.gov Identifier: NCT04858438
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : April 2, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This procedure only applies to women.
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858438


Contacts
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Contact: Gabriella Rustia, MD 313-343-6708 gabriella.rustia@ascension.org
Contact: Muhammad F Aslam, MD 313-343-3494 muhammad.aslam@ascension.org

Locations
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United States, Michigan
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Gabriella M Rustia, MD       gabriella.rustia@ascension.org   
Contact: Muhammad F Aslam, MD       muhammad.aslam@ascension.org   
Sponsors and Collaborators
Ascension South East Michigan
More Information
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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT04858438    
Other Study ID Numbers: 1716019
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascension South East Michigan:
Sacrocolpopexy
Pneumoperitoneum
Postoperative pain
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical