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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07710352
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight
  • Pneumoperitoneum
  • Robotic Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AirSeal Robotic Solution — DEVICE
    The experimental intervention is low-pressure pneumoperitoneum at 8 mmHg using the AirSeal Robotic Solution device. The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery. It consists of a console, tri-lumen filtered tube set, and access ports that function as valveless trocars. The console of the device is mounted on a cart and regulates carbon dioxide flow and smoke evacuation by continuously measuring the intra-abdominal pressure. The trilumen filtered tube set carries carbon dioxide to the abdomen, transmits pressure information back to the console, and returns gas from the abdomen for smoke evacuation and filtration. These features allow for the device to operate in the "AirSeal" mode, whereby the pressure within the abdomen is effectively kept constant. The valveless trocars are access ports for the minimally invasive tools to enter the abdominal cavity.
  • Standard-pressure pneumoperitoneum (15 mmHg) — OTHER
    The control intervention is standard-pressure pneumoperitoneum set at a pressure of 15 mmHg. This will be delivered using the operating room's conventional valved-trocar carbon dioxide insufflator.

Study Details

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?

Key Dates

First listed
Jul 17, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Low-pressure pneumoperitoneum (AirSeal)
    Participants who are assigned to this arm will receive 8 mmHg pneumoperitoneum using the AirSeal Robotic Solution device. The AirSeal Robotic Solution device is a FDA 510(k)-cleared carbon dioxide insufflation platform with valveless trocar technology that helps to maintain stable intra-abdominal pressure during surgery.
  • Active Comparator: Standard-pressure pneumoperitoneum
    Participants who are assigned to this arm will receive 15 mmHg pneumoperitoneum using the conventional insufflation machine at New York-Presbyterian/Weill Cornell Medical Center.

Primary Outcome Measure

Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order [ Time Frame: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric SurgeryNew YorkNew York10021
Cheguevara Afaneh, MD
[email protected]
(646) 962-8462
Cheguevara Afaneh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery· New York, NY

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