Assessment of Leakage Rate of Ileo-colic Sutured Anastomoses Using Polydioxanone Suture After Right Hemicolectomy for Cancer

What this Trial Is About

Researchers are studying patients with right colon cancer who are undergoing elective right hemicolectomy surgery to remove part of the colon. The study aims to evaluate the leakage rate of the ileo-colic anastomosis, which is the connection made between the ileum and colon after surgery. The goal is to see if using MonoPlusae suture material for this connection results in a leakage rate that is not worse than rates reported for other hand-sewn or stapled anastomosis techniques. Anastomosis leakage is an important complication that can cause further health problems in these patients. The study involves patients who receive a primary anastomosis without a protective stoma during either open or laparoscopic right hemicolectomy or extended hemicolectomy surgery. The ileo-colic anastomosis is constructed using MonoPlusae suture material, either fully hand-sewn or partially sutured combined with stapling. The surgery may be performed by open, laparoscopic, or converted approaches. This device-based observational study monitors how well the suture material handles during surgery and tracks patient outcomes after the procedure. Participants will be followed for up to one year after surgery. Researchers will assess anastomosis leakage rates within the first 30 days after surgery as the primary outcome. Secondary outcomes include complication rates at discharge, 30 days, and 1 year postoperatively; mortality rates; surgical site infections; hospital stay length; patient satisfaction; quality of life; bowel function; and hernia rates. Various clinical assessments, questionnaires, and observations will be performed to collect this data, providing a comprehensive view of patient recovery and safety over time.

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy