Low Gas Pressure vs Standard Gas Pressure in Weight-Loss Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AirSeal Robotic Solution, Standard-pressure pneumoperitoneum (15 mmHg).
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Robotic Surgery, Pneumoperitoneum. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between Low Pressure (8 mmHg) AirSeal Insufflation vs Standard Pressure (15 mmHg) Pneumoperitoneum on Postoperative Recovery in Bariatric Surgery: A Randomized Controlled Trial
Overview
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?
Detailed description
Minimally invasive bariatric surgeries require the use of pneumoperitoneum, which is a standard of care as it creates a working environment to utilize minimally invasive tools to accomplish surgical procedures. However, there is no uniform standard pressure (usually between 12-15 mmHg). Moreover, maintaining the same pressure throughout the procedure can be inconsistent at best. Elevations in pneumoperitoneum cause significant stretch to the peritoneum which results in significant postoperative pain, longer post-anesthesia care unit (PACU) stay times, and higher opioid consumption. These effects are amplified to a higher degree in patients with severe obesity. If the pressures can be maintained and set to lower levels, then patients may have the opportunity to recover in the immediate postoperative period.
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.
This study is a prospective, single-center, single-blind, double-arm parallel-group randomized controlled trial that aims to determine if the use of low-pressure (8 mmHg) AirSeal insufflation, compared to standard-pressure (15 mmHg) pneumoperitoneum, provides superior patient outcomes in terms of post-operative recovery time and convalescence.
During the preoperative evaluation, participants will be consented and enrolled into the trial. Participants will then be randomly allocated to either low-pressure AirSeal insufflation (8 mmHg) or standard-pressure pneumoperitoneum (15 mmHg). Patients and outcome assessors will be blinded to allocation; however, for safety purposes, the operating surgeon and anesthesiologist cannot be blinded.
Intraoperative data (including operation time, estimated blood loss, abdominal pressure, and pressure deviations) will be recorded. Participant data related to comorbidities (i.e. body mass index, American Society of Anesthesiologists physical status, hypertension, diabetes, obstructive sleep apnea, chronic obstructive pulmonary disease/asthma, and smoking status) will be collected from the electronic medical record.
Interventions
- Device AirSeal Robotic Solution
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 cont - Other Standard-pressure pneumoperitoneum (15 mmHg)
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.
Primary outcome measures
- 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)]
Secondary outcome measures (12)
- Average numeric rating scale (NRS) pain score (0-10) at PACU admission [Time frame: PACU arrival (5 minutes post-surgery)]
- Average numeric rating scale (NRS) pain score (0-10) at PACU discharge [Time frame: PACU discharge (1-4 hours post-surgery)]
- Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1) [Time frame: Post-operative day 1 (24 hours after surgery)]
- Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3) [Time frame: Post-operative day 3 (72 hours after surgery)]
- Average morphine milligram equivalents (MME) in the post-anesthesia care unit (PACU) [Time frame: PACU arrival to PACU discharge (1-4 hours post-surgery)]
- Average morphine milligram equivalents (MME) over the first 24-hour post-operative period [Time frame: Post-operative day 1 (24 hours after surgery)]
- Proportion of participants experiencing postoperative nausea or vomiting in the post-anesthesia care unit (PACU) [Time frame: PACU arrival to PACU discharge (1-4 hours post-surgery)]
- Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 1 (POD1) [Time frame: Post-operative day 1 (24 hours after the surgery)]
- Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 3 (POD3) [Time frame: Post-operative day 3 (72 hours after the surgery)]
- Proportion of participants who require intra-operative conversion from robotic-assisted surgery to open surgery [Time frame: During the surgery (about 60 to 240 minutes)]
- Proportion of participants with clinical or radiographic subcutaneous emphysema [Time frame: From start of surgery to PACU discharge (1-4 hours after surgery)]
- Proportion of participants who sustained intraoperative pressure elevation (defined as sustained increase to ≥12 mmHg for ≥10 minutes in the AirSeal arm) [Time frame: During the surgery (about 60 to 240 minutes)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery — New York
Identifiers
NCT: NCT07710352 · 26-05030301