Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06504277

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

The participant must meet all of the inclusion criteria to eligible for this clinical trial:

  1. All ages > or = to 18 years old;
  2. Must be deemed to have capacity to provide informed consent;
  3. Must sign and date the informed consent form;
  4. Stated willingness to comply with all study procedures;
  5. Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;
Not Eligible

You will not qualify if you...

An individual who meets any of the following criteria will be excluded from participation in this clinical trial:

  1. Previous midline laparotomy;
  2. Gynecological cancer beyond stage 1 disease;
  3. Chronic pain;
  4. Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;
  5. Fibromyalgia;
  6. BMI >50;
  7. Language barrier;
  8. 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

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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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Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain | DecenTrialz