What this study is
During 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 robotic 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 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?
What's being tested
- AirSeal Robotic Solution
Intervention · 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)
Intervention · 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
- Official title
- Comparison Between Low Pressure (8 mmHg) AirSeal Insufflation vs Standard Pressure (15 mmHg) Pneumoperitoneum on Postoperative Recovery in Minimally Invasive Robotic Surgery: A Randomized Controlled Trial
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Robotic Surgery · Pneumoperitoneum
- Enrolling
- 100 people
- Starts
- 2026-07-30
- Est. completion
- 2027-02
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Aged 18 years or older
- Scheduled to undergo robotic-assisted surgery at New York-Presbyterian/Weill Cornell Medical Center
- American Society of Anesthesiologists physical status I-III
- Able to understand and provide written informed consent in English
You can't join 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 surgeries
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNew York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery
New York, New York, United States
- Cheguevara Afaneh, MD · Contact(646) 962-8462cha9043@med.cornell.edu
- Cheguevara Afaneh, MD · Principal investigator
Recruiting
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 26-05030301
Principal investigator
Cheguevara Afaneh, MD
New York-Presbyterian/Weill Cornell Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.