Comparing Leak Testing Versus No Leak Testing in Colorectal Cancer Surgery to Prevent Anastomotic Complications

What this Trial Is About

Researchers are evaluating the effectiveness of gastroscopy, air, and methylene blue GAM leak testing in reducing postoperative complications, especially anastomotic leakage, after colorectal cancer surgery. The study focuses on patients with colorectal cancer undergoing surgery and aims to compare clinical outcomes between those who receive leak testing during surgery and those who do not. The primary outcome is the incidence of anastomotic leaks within 30 days after surgery. Participants are divided into groups based on tumor location rectal cancer 5 cm from the anus or colorectal cancer > 5 cm and whether they received preoperative chemotherapy. Some groups receive intraoperative leak testing after the anastomosis is completed, which involves checking the anastomosis integrity using gastroscopy, warm saline immersion, air filling, and methylene blue injection. Others do not receive leak testing. This randomized, double-blind trial compares these groups to assess the impact of leak testing. During the study, participants are monitored for postoperative complications, especially anastomotic leaks, for 30 days following surgery. Researchers will collect data on the number of patients experiencing leaks and other complications. The study involves follow-up assessments within the first month after surgery to evaluate safety and outcomes. Participation lasts through the surgical treatment and the 30-day postoperative observation period.

Efficacy and Safety of Colorectal Anastomotic Leak Testing