Extra-Peritoneal Tunneling Versus Conventional Drain Fixation After Anterior or Low Anterior Resection

The goal of this clinical trial is to learn whether the extra-peritoneal tunneling (EPT) drain fixation method works better and more safely than the conventional drain insertion method after rectal cancer surgery. It will also learn about the safety and possible complications of the EPT technique. The main questions it aims to answer are: Does the EPT drain fixation method increase the success rate of conservative management (drain maintenance and/or antibiotics) when an anastomotic leak occurs? Does the EPT method reduce the rate of drain displacement compared with the conventional method? Are there any safety concerns or complications associated with the EPT method? Researchers will compare EPT drain fixation to the conventional drain method to see which approach provides better outcomes after anterior or low anterior resection for rectal cancer. Participants will: Undergo anterior or low anterior resection for rectal cancer as part of their standard surgical treatment. Be randomly assigned to either the EPT drain fixation group or the conventional drain group. Receive the same postoperative care as usual, including follow-up imaging to monitor drain position and recovery. Be observed for postoperative outcomes such as anastomotic leakage, drain position, and related complications until recovery. This study will help determine whether securing the drain through an extra-peritoneal tunnel can prevent drain movement, improve early management of leakage, and enhance patient recovery after rectal surgery.

NCT Number	NCT07241143
Lead Sponsor	Yeungnam University Hospital Collaborators: Konyang University Hospital, Daegu Catholic University Medical Center, Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Chungnam National University Hospital, Chungbuk National University Hospital, Keimyung University Dongsan Medical Center, Pusan National University Yangsan Hospital, Chonbuk National University Hospital, Kyungpook National University Chilgok Hospital, Yonsei University Yongin Severance Hospital, Chonnam National University Hospital, Ewha Womans University Seoul Hospital, Soonchunhyang University Hospital, Hallym University Dongtan Sacred Heart Hospital
Conditions	Rectal Diseases, Sigmoid Colon Disease, Rectal Cancer, Sigmoid Colon Cancer
Enrollment	596 participants
Start Date	2025-12-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-11-21