NOT YET RECRUITING
NCT07782580
Low-Pressure AirSeal Versus Conventional Insufflation in Major Minimally Invasive Hepatopancreatobiliary Surgery
When performing minimally invasive (MIS) hepato-pancreato-biliary (HPB) surgery, an air seal is used for optimal space and visibility of the surgical field. This is typically done at a pressure of 10-15 mmHg, but can also come with risks of serious complications. HBP surgeries are high risk, prolonged, and complex, which all come with their own difficulties. Current pressure systems have shown pressure instability and leak conditions such as changing instruments and suctioning. When there is instability this can cause loss of visibility of the surgical field, which in complex surgeries, can lead to further complications.
Lower pneumoperitoneum pressures may improve respiratory mechanics and early recovery but can be limited by poor exposure, smoke, and field instability. AirSeal's valveless system with continuous smoke evacuation may enable low-pressure surgery more reliably. Before a definitive efficacy trial, the investigators need to confirm feasibility of maintaining low pressure in major HPB cases and patient safety, while estimating effects on perioperative recovery and complications.
Gender: All
Ages: 18 Years - Any
Hepato-Pancreato-Biliary Conditions Requiring Minimally Invasive Surgery