Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Cheguevara Afaneh, MD
CONTACT
Lead
Weill Medical College of Cornell University
Robotic 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
