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

NARecruitingINTERVENTIONAL
Enrollment

968

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2030

Conditions
Anastomotic Leak
Interventions
DEVICE

Modified Transanal Drainage Tube

Patients with rectal adenocarcinoma will undergo elective laparoscopic/robotic low anterior resection. After the anastomosis is completed and the air leak test is confirmed to be negative, a modified TDT (occlusive balloon catheter) will be inserted. The balloon will be placed 5 cm above the anastomosis and filled under laparoscopic visualization (approximately 25 ml) to slightly dilate the intestinal lumen and occlude the intestinal cavity (under laparoscopic monitoring to ensure it does not affect the blood supply of the intestine). The external part of the tube will be sutured to the perianal skin and further secured with a 3M transparent dressing on the outside. It will be connected to a drainage bag (with an inner diameter greater than 8 mm) and left in place for 7 days, or until the drainage function is lost due to obvious defecation around the anal tube, at which point the catheter will be removed.

Trial Locations (1)

400042

RECRUITING

Army Medical Center (Daping Hospital), Yuzhong

All Listed Sponsors
lead

Third Military Medical University

OTHER