The LOw PRESSuRE Trial: Laparoscopic Optimization With Pressure Reduction

Launched by MOUNT SINAI HOSPITAL, CANADA · Jul 10, 2024

Keywords

ClinConnect Summary

The LOw PRESSuRE Trial is studying a new approach to laparoscopic surgery, which is a type of minimally invasive surgery often used for gynecological procedures. The trial aims to compare two different levels of pressure used during the surgery: low pressure (10 mm Hg) and standard pressure (15 mm Hg). Researchers hope to find out if using lower pressure can help reduce pain and improve recovery after surgery. Participants will be randomly assigned to one of the two groups, and the surgeons performing the procedures will not know which pressure they are using to ensure fair results.

To be eligible for this study, participants must be women aged 18 or older who are scheduled for specific surgeries, such as the removal of ovaries or ovarian cysts. They need to be able to understand and sign the consent form, agreeing to follow all study procedures. However, individuals with certain conditions, like previous major abdominal surgery or certain types of chronic pain, will not be able to participate. If you join this trial, you can expect to have your recovery and pain levels monitored closely after the surgery, helping researchers learn more about the best practices for patient care.

Gender

FEMALE

Eligibility criteria

• 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;