NCT02686567

Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer

The Use of the Transanal Drainage Tube for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Medium & Low Rectal Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (actual)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium \& low rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for deduce the rate. There were several studies, but most of them were not randomized controlled trial (RCT) studies. There was only one RCT study with enough samples, but it was designed for open anterior resection, and the patients underwent diverting stoma were excluded, so there was the selection bias. LAR now is thought to been with the same effect, and it is safe and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic leakage after LAR for medium \& low rectal cancer is needed.

Detailed description

Patients were randomly assigned to two groups, the TDT and non-TDT group after the laparoscopic LAR and DST procedure was decided during operation. Randomization was obtained through a computer-generated random number sequence allocation. Surgeon blinding was performed to ensure all the intraoperative decisions made by the surgeon were not interfered with by the grouping. All the operative procedures fully complied with the guideline for the diagnosis and treatment of colorectal cancer and the technique of total mesorectal excision (TME). The preservation of the left colonic artery was judged by the surgeon according to his own experiences and assessment of the patient's conditions. When the anastomosis was accomplished, the discretion of DS construction was made by the surgeon based on assessing the risk factors of AL. Pelvic drainages were used in all cases in this study. After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results.

Conditions

• Anastomotic Leakage
• Rectal Neoplasms

Interventions

Type	Name	Description
PROCEDURE	with TDT	After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results. In this group, a silicone tube (28Fr, Sumitomo Bakelite Co, Japan) was inserted through the anus and the tip of the tube was placed approximately 5 cm above the anastomosis at the end of the surgery in patients from the TDT group. The tube was fixed with a skin suture and connected to a drainage bag. TDT was planed to remove 3-7 days after surgery and early removal was allowed if the patient experienced intolerable pain.
PROCEDURE	without TDT	After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2016-02-19
• Last updated: 2021-05-07

Locations

1 site across 1 country: China