Low Gas Pressure for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using a lower gas pressure with the AirSeal Robotic Solution device during robotic surgery can reduce pain and speed up recovery. Surgeries typically use a standard pressure of 15 mmHg, which can cause post-procedure pain. The study compares this standard pressure to a lower pressure of 8 mmHg with the AirSeal device to determine if it shortens recovery time and reduces the need for pain medications. Adults undergoing robotic surgery at New York-Presbyterian/Weill Cornell Medical Center, who do not have severe health issues or chronic opioid use, might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative surgical techniques that could improve recovery experiences.
What prior data suggests that the AirSeal device is safe for use in robotic surgery?
Research has shown that the AirSeal Robotic Solution is generally safe for surgeries. Studies indicate that using AirSeal at a lower pressure can reduce post-surgery pain, shorten hospital stays, and speed up recovery. One study found that using AirSeal at low pressure in patients with sickle cell disease led to fewer post-surgery complications. Another study suggested that AirSeal is safe for children, as it did not negatively impact surgical outcomes. Additionally, AirSeal helps maintain a stable environment during surgery, allowing surgeons to work more efficiently. Overall, AirSeal is well-tolerated and can enhance the comfort of the surgical experience for patients.12345
Why are researchers excited about this trial?
Researchers are excited about the Low Gas Pressure for Obesity trial because it explores a new surgical technique using the AirSeal Robotic Solution. Unlike traditional methods that use higher pressure during laparoscopic surgery, the AirSeal system maintains a stable intra-abdominal environment with a lower pressure of 8 mmHg, compared to the standard 15 mmHg. This could potentially reduce post-operative pain and improve recovery times. By using a valveless trocar technology, it aims to enhance the surgical experience and patient outcomes, making it a promising development in obesity treatment.
What evidence suggests that using lower gas pressure with the AirSeal device is effective for reducing pain and speeding recovery after robotic surgery?
Research has shown that using the AirSeal system with low pressure during robotic surgery can help reduce postoperative pain. In this trial, participants in the low-pressure pneumoperitoneum arm will receive 8 mmHg pneumoperitoneum using the AirSeal Robotic Solution device. Studies have found that this method enhances anesthesia effectiveness, potentially speeding up recovery. It also maintains steady abdominal pressure and reduces surgical smoke. Patients who underwent surgery with the AirSeal system reported less pain afterward, suggesting it might be more comfortable than standard methods. Overall, this approach appears promising in shortening recovery time and increasing patient comfort.678910
Who Is on the Research Team?
Cheguevara Afaneh, MD
Principal Investigator
New York-Presbyterian/Weill Cornell Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are scheduled to have robotic weight-loss surgery (either sleeve gastrectomy or Roux-en-Y gastric bypass) at New York-Presbyterian Hospital/Weill Cornell Medical Center.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Evaluation
Participants are consented and enrolled into the trial, and randomly allocated to either low-pressure AirSeal insufflation or standard-pressure pneumoperitoneum
Surgery
Participants undergo robotic-assisted surgery with either low-pressure AirSeal or standard-pressure pneumoperitoneum
Post-Anesthesia Care Unit (PACU) Recovery
Participants recover from anesthesia in the PACU, with monitoring of pain scores and opioid consumption
Follow-up
Participants are monitored for postoperative pain and recovery, including pain scores on post-operative days 1 and 3
What Are the Treatments Tested in This Trial?
Interventions
- AirSeal Robotic Solution
Trial Overview
The study compares two ways of inflating the belly during robotic weight-loss surgery: using a lower gas pressure with the AirSeal device versus standard gas pressure. The goal is to see if lower pressure reduces pain and speeds up recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Citations
Bariatric Surgical Solutions
"I have noticed a significant decrease in peak inspiratory airway pressure and mean airway pressure while using the AirSeal® system.
Review of contemporary role of robotics in bariatric surgery
The review showed that the use of robotics led to similar or lower complication rate in bariatric surgery when compared with laparoscopy.
Retrospective Study Of The AirSeal(tm) System For ...
The Airseal(tm) system group saved 12.3 mins in the operating room on average. This saves about $345.00 per case on operating room time.
Robotic Bariatric Surgery | Bypass vs Sleeve | Da Vinci ...
Learn about robotic bariatric surgeries such as sleeve gastrectomy, gastric bypass, SADI-S, and BPD/DS. Hear from patients who have undergone da Vinci ...
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medhold.co.za
medhold.co.za/wp-content/uploads/2025/09/LowPressureInBariatricProcedures_ProductBrochure-1.pdfLow Pressure In Bariatric Procedures
Clinical studies suggest utilizing low-pressure insufflation with AirSeal improved anesthesia parameters and reduce postoperative pain.1-8
Prospective randomized controlled trial on comparison of ...
This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder ...
AirSeal Clinical Study Appendix
Low stable pneumoperitoneum pressure with AirSeal in sickle cell disease (SCD) patients is associated with a significantly reduced incidence of post-operative
Discover how the AirSeal® System is transforming ...
The system allows for smaller incisions … can lead to reduced pain, quicker recovery times, and minimized scarring for patients. American ...
Safety and efficacy of AirSeal continuous pressure ...
Our study aims to understand AirSeal 's safety and efficacy. AirSeal 's safety across different types of laparoscopic/robot-assisted cases,
Safety and Efficacy of AirSeal Continuous Pressure ...
This study suggests AirSeal® is safe to use in children weighing less than 20kg, as its use did not affect intra- and post-operative outcomes in a
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