Actively Recruiting
Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
Led by Mount Sinai Hospital, Canada · Updated on 2025-07-31
82
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
M
Mount Sinai Hospital, Canada
Lead Sponsor
W
Women's College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
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;
You will not qualify if you...
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;
AI-Screening
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Trial Site Locations
Total: 1 location
1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
Research Team
S
Sara Hojabri, MBBCHBAO
CONTACT
M
Mara Sobel, MD, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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