Observational Study on Postoperative Pancreatic Fistula Rates After Distal Pancreatectomy Using the AEON Endostapler

What this Trial Is About

Researchers are conducting a prospective, observational study to evaluate the rate of postoperative pancreatic fistula POPF in patients undergoing distal pancreatectomy DP using the AEON1732 Endostapler. POPF is a serious complication after DP, and this study aims to better understand its incidence to improve surgical techniques and healthcare outcomes. The study involves 110 patients who are scheduled for DP for various reasons and who provide informed consent. The study focuses on patients undergoing minimally invasive or open DP, with or without splenectomy or left adrenalectomy. There is no intervention assigned since this is an observational study assessing the use of the AEON1732 Endostapler during surgery. Follow-up evaluations occur at postoperative days 1, 3, 14, 30, and 90 to monitor outcomes and complications. Participants will have their pancreatic leakage monitored by measuring amylase levels in drain fluid at set intervals after surgery. Researchers will collect data on the primary outcome, which is the rate of clinically relevant POPF according to International Study Group of Pancreatic Fistula criteria, along with secondary perioperative parameters like blood loss, operation time, ICU and hospital stays, reoperation rates, and 90-day mortality. The total study period extends up to 90 days post-surgery for each participant.

Assessing Pancreatic Fistula Rates After Distal Pancreatectomy Using AEON Endostapler