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

Launched by THIRD MILITARY MEDICAL UNIVERSITY · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help prevent a common complication called anastomotic leakage, which can happen after surgery for rectal cancer. Anastomotic leakage occurs when the connection made between two parts of the intestine after tumor removal doesn’t heal properly, causing leaks. This can lead to serious problems like longer hospital stays, extra surgeries, and even affect long-term recovery. The trial is testing a modified drainage tube that is placed through the anus before surgery. This tube helps remove gas and waste from the intestines, reducing pressure on the healing area. Unlike older versions, this new tube can be cleaned after surgery and has a balloon that blocks waste from harming the surgical site.

People who might join this trial are adults between 18 and 80 years old who have rectal cancer located close to the anus and are scheduled for a specific type of surgery that saves the anal sphincter (the muscle that controls bowel movements). Participants need to be healthy enough for surgery and able to understand the study details. Those with emergency surgeries, certain other health issues, or who are pregnant cannot join. If you take part, you will be randomly assigned to receive either the modified drainage tube or standard care, and doctors will monitor your recovery to see if the new tube helps prevent leakage. This trial hopes to find a simple and effective way to improve healing after rectal cancer surgery and reduce complications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Rectal adenocarcinoma (confirmed by pathology);
• • Tumor location: The lower edge is ≤10 cm from the anal verge;
• • Age: ≥18 and ≤80 years old;
• • ASA ≤3 ;
• • After assessment, laparoscopic/robotic sphincter - preserving surgery for rectal cancer is feasible;
• • T2 - 4N0 - 3M0\~T0 - 1N1 - 3M0 \& non- local recurrence;
• • Signed informed consent form;
• • Able to understand the risks of participating in the trial.
• Exclusion Criteria:
• • Emergency surgery;
• • Presence of multiple primary colorectal cancers;
• • History of long - term use of immunosuppressants or corticosteroids;
• • Patients with severe mental illness or uncontrolled infection before surgery;
• • Pregnant or breastfeeding women;
• • Bowel obstruction before surgery.