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Low Gas Pressure vs Standard Gas Pressure in Weight-Loss Surgery

Not Yet RecruitingNA

Sponsor: Weill Medical College of Cornell University

Conditions: Obesity & Overweight, Robotic Surgery, Pneumoperitoneum

Interventions: AirSeal Robotic Solution, Standard-pressure pneumoperitoneum (15 mmHg)

Countries: United States

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?

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

New York, New York, United States