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

NCT07710352 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-05030301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does using lower gas pressure shorten the time people spend in the recovery room after surgery?
2. 2.Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?

Conditions

Obesity & Overweight; Robotic Surgery; Pneumoperitoneum

Keywords

bariatric surgery; robotic surgery; low-pressure pneumoperitoneum; obesity; recovery time; pain; pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

• Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order

  The PACU is the area where participants recover from anesthesia after surgery. The PACU recovery time will be computed in minutes as the interval between the documented PACU arrival timestamp and the documented PACU discharge-order timestamp which will both be abstracted from the institutional electronic medical record. The discharge-order timestamp represents the clinical decision that the participant is fit to leave the PACU and is therefore not confounded by factors such as transport delays.

  From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)

Secondary Outcomes (12)

• Average numeric rating scale (NRS) pain score (0-10) at PACU admission

  PACU arrival (5 minutes post-surgery)

• Average numeric rating scale (NRS) pain score (0-10) at PACU discharge

  PACU discharge (1-4 hours post-surgery)

• Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1)

  Post-operative day 1 (24 hours after surgery)

• Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3)

  Post-operative day 3 (72 hours after surgery)

• Average morphine milligram equivalents (MME) in the post-anesthesia care unit (PACU)

  PACU arrival to PACU discharge (1-4 hours post-surgery)

Study Arms (2)

Low-pressure pneumoperitoneum (AirSeal)

EXPERIMENTAL

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.

Device: AirSeal Robotic Solution

Standard-pressure pneumoperitoneum

ACTIVE COMPARATOR

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.

Other: Standard-pressure pneumoperitoneum (15 mmHg)

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.

Low-pressure pneumoperitoneum (AirSeal)

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.

Standard-pressure pneumoperitoneum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Pneumoperitoneum; Pain

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peritoneal Diseases; Digestive System Diseases; Neurologic Manifestations

Study Officials

• Cheguevara Afaneh, MD

  New York-Presbyterian/Weill Cornell Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheguevara Afaneh, MD

CONTACT

(646) 962-8462; cha9043@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be performed using a computer-generated permuted block sequence pre-loaded into REDCap with allocation concealed until the day of surgery. Allocation will be blinded to participants and outcome assessors. Surgical staff cannot be blinded to allocation for safety reasons.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)