Status:
RECRUITING
Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Women's College Hospital
Conditions:
Surgery
Laparoscopic
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 lapa...
Detailed Description
Primary Objective: The primary objective of this study is to determine the effect of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum on post-operative shoulder pain on post operati...
Eligibility Criteria
Inclusion
- The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- 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;
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- Previous midline laparotomy;
- Gynecological cancer beyond stage 1 disease;
- Chronic pain;
- Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
- Fibromyalgia;
- BMI \>50;
- Language barrier;
- Inability to communicate or provide informed consent;
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06504277
Start Date
July 2 2025
End Date
September 15 2026
Last Update
July 31 2025
Active Locations (1)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2