Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer
Condition: Anastomotic Leakage; Rectal Neoplasms
MeSH terms: Rectal Neoplasms; Anastomotic Leak
Study type: Interventional

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.
    

Intervention name(s): with TDT; without TDT
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.
Other intervention name(s): with transanal drainage tube; without transanal drainage tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: transanal drainage tube; anastomotic leakage; laparoscopic anterior resection; rectal cancer