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

NCT02686567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

  • Anastomotic Leakage
  • Rectal Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

  • Tong weidong, Professor · Daping Hospital, Third Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02686567 on ClinicalTrials.gov