A Randomized Controlled Trial (RCT) Comparing the Effect of Low Versus Standard Pressure Pneumoperitoneum on Post-operative Shoulder Tip Pain in Patients Undergoing Laparoscopic Gynecologic Surgery for Benign Indications

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This proposed study is a single-center, double blind, parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Patients will be randomized to the control group (standard pressure) or the intervention group (low pressure) and surgeons will be blinded to the study pressure. Data on post-operative recovery and pain scores will be recorded for each patient.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• All ages \> or = to 18 years old;

• Must be deemed to have capacity to provide informed consent;

• Must sign and date the informed consent form;

• Stated willingness to comply with all study procedures;

• Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;

Locations
Other Locations
Canada
Women's College Hospital
RECRUITING
Toronto
Contact Information
Primary
Sara Hojabri, MBBCHBAO
sara.hojabri@mail.utoronto.ca
6474047614
Backup
Mara Sobel, MD, MSC
mara.sobel@sinaihealth.ca
9055155186
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 82
Treatments
Active_comparator: Standard Pressure
Patients undergoing laparosocpy at standard pressure (15 mm Hg)
Experimental: Low Pressure
Patients undergoing experimental intervention of low pressure pneumoperitoneum (10 mm Hg)
Related Therapeutic Areas
Sponsors
Collaborators: Women's College Hospital
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov