Study of Modified Transanal Drainage Tube to Prevent Leakage After Rectal Cancer Surgery Randomized Trial in Patients Undergoing Laparoscopic or Robotic Low Anterior Resection

What this Trial Is About

Researchers are evaluating a modified transanal drainage tube TDT to prevent anastomotic leakage AL after low anterior resection in patients with rectal cancer. AL is a common complication that increases hospital stays, secondary surgeries, and mortality, while also raising the risk of cancer recurrence and reducing survival. This randomized clinical trial aims to compare the modified TDT, which allows postoperative irrigation and blocks feces from affecting the anastomosis, against no modified TDT to assess its effectiveness in reducing AL and related complications. Participants will be randomly assigned to either a group receiving the modified TDT or a group without it. All patients will undergo elective laparoscopic or robotic low anterior resection following colorectal cancer surgery guidelines, with surgeons deciding on additional procedures during surgery without bias from group assignment. The modified TDT is inserted after anastomosis completion and left in place for 7 days or until no longer functional. Both groups receive pelvic drainage, and surgeons follow standardized techniques to preserve arteries and assess the need for diverting stomas. During the study, participants will be monitored from surgery completion up to 30 days for AL incidence and grades, with follow-up extending to one year for anastomosis-related complications and up to three years for disease-free survival and local recurrence rates. Perianal pain will be assessed on postoperative days 1, 3, and 5. The study includes regular evaluations to track safety, effectiveness, and long-term outcomes related to the use of the modified drainage tube.

PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage