Recruiting

Low Pressure vs. Standard Pressure

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT06504277

Conditions

Surgery

Laparoscopic

Laparoscopy

Penumoperitoneum

Post-operative Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Low Pressure Penumoperitoneum

Standard Pressure Group (No intervention- active comparator)

Study Details

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 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

Surgery

Laparoscopic

Laparoscopy

Penumoperitoneum

Post-operative Pain

Study ID

NCT06504277

Start date

Jul 2, 2025

Status verified date

Jul, 2025

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Jul 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria: 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;

Exclusion Criteria: 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;

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Low Pressure Penumoperitoneum

Maintained Pneumoperitoneum with low pressure of 10 mm Hg

Standard Pressure Group (No intervention- active comparator)

Maintained Pneumoperitoneum at standard pressure of 15 mm Hg

Primary outcome measure

  • Shoulder Tip Pain [ Time Frame: Post-op day 1 ]

Central Contacts and Locations

Central contacts

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2025-07-31.