Pain After Insufflation for Robotic Sacrocolpopexy (PAIRS) Trial

A

Ascension South East Michigan

Status

Unknown

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: Insufflation during surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04858438
1716019

Details and patient eligibility

About

This study evaluates post-operative pain between different insufflation pressures during robotic-assisted sacrocolpopexy. Subjective pain and narcotic usage after surgery will be measured.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Standard Insufflation Group
Active Comparator group
Description:
Patients will receive standard insufflation during surgery (15 mm Hg).
Treatment:
Procedure: Insufflation during surgery
Low Insufflation Group
Experimental group
Description:
Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).
Treatment:
Procedure: Insufflation during surgery

Trial contacts and locations

0

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Central trial contact

Gabriella Rustia, MD; Muhammad F Aslam, MD

Data sourced from clinicaltrials.gov

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