BridgeMD
Compares treatment options for Surgery
Official title Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain
ClinicalTrials.gov ID: NCT06504277
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- The participant must meet all of the 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;
You likely can't join if
- 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;
See the full eligibility criteria
- The participant must meet all of the 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;
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.