Low Gas Pressure vs Standard Gas Pressure in Weight-Loss Surgery (NCT07710352) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low Gas Pressure vs Standard Gas Pressure in Weight-Loss Surgery
United States100 participantsStarted 2026-07
Plain-language summary
During weight-loss surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery.
The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during weight-loss surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.
The study includes adults aged 18 or older having robotic weight-loss surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) at New York-Presbyterian Hospital/Weill Cornell Medical Center.
The main questions this clinical trial aims to answer are:
1. Does using lower gas pressure shorten the time people spend in the recovery room after surgery?
2. Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or older
* Scheduled to undergo robotic-assisted Roux-en-Y gastric bypass or sleeve gastrectomy at New York-Presbyterian/Weill Cornell Medical Center
* Obesity (body mass index≥40kg/m2 or ≥35kg/m2 with serious obesity-related health conditions)
* American Society of Anesthesiologists physical status I-III
* Able to understand and provide written informed consent in English
Exclusion Criteria:
* American Society of Anesthesiologists physical status IV or higher (i.e. a severe systemic disease that is a constant threat to life such as decompensated heart failure)
* Chronic opioid use (≥30 morphine milligram equivalents per day for ≥30 days within the past 6 months)
* Current pregnancy
* Inability to understand and provide informed consent in English
* Inability to provide informed consent due to cognitive impairment or other conditions impacting decision-making capacity
* Scheduled open or laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order
Timeframe: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)
Trial details
NCT IDNCT07710352
SponsorWeill Medical College of Cornell University