Single Port Insufflation RCT

Completed · Not applicable

Conditions studied: Postoperative Pain Score

In brief

The goal of this clinical trial is to learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. The main question it aims to answer is: Does minimally decreasing insufflation pressure improve postoperative pain? Researchers will compare standard insufflation pressure (15 mmHg) to experimental insufflation pressure (12 mmHg) to see if it insufflation pressure impacts patient's postoperative pain. Once a participants agrees to participate in our study, they will receive either standard or experimental pressure at the time of surgery. Postoperative pain scores in the postoperative anesthesia care unit and at postoperative day 1 and 14 visits will be recorded. Participants will also be asked to complete the Patient Global Impression of Improvement at the 14 day visit.

Key facts

Study ID

NCT06990750

Run by

University of Chicago

People needed

70

Starts

2024-04-01

Expected to finish

2025-04-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult women scheduled for single port robotic sacrocolpopexy for uterovaginal or vaginal vault prolapse

You may not qualify if…

• Non-english speaking
• Inability to complete study questionnaires

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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