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Single Port Insufflation RCT

NCT06990750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Pain Score

Interventions

PROCEDURE

15 mmHg

Insufflation pressure was set to 15 mm Hg at the time of single port robotic sacrocolpopexy.

PROCEDURE

12 mmHg

Insufflation pressure was set to 12 mm Hg at the time of single port robotic sacrocolpopexy.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Margaret G Mueller, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990750 on ClinicalTrials.gov