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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anastomotic Leakage, Rectal Neoplasms

Intervention / Treatment
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* Procedure: with TDT
* Procedure: without TDT


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: all consecutive 18 to 80 years old individuals diagnosed as primary rectal adenocarcinoma with the lower edge of the tumor less than 10 cm from the anal verge were considered eligible; with the classification of American Society of Anaesthesiologist (ASA) of I, II, or III; Laparoscopic LAR+ with double stapling technique (DST) was planned to perform for the patients. All the preoperative procedures should comply with the guideline for the diagnosis and treatment of colorectal cancer. Exclusion criteria: The emergency operation for rectal cancer with obstruction, bleeding, or perforation would be excluded. Patients with inflammatory bowel disease (IBD), familial adenomatous polyposis (FAP), recurrent rectal cancer, or synchronous cancer would not be suitable. Patients with preoperative radiotherapy were excluded. Patients who underwent other types of surgeries for rectal cancer, including Hartmann's procedure, abdominoperineal resection (APR), intersphincteric resection ( ISR), et al. were excluded intraoperatively

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with TDT<br>with TDT | Procedure: with TDT<br>* 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.<br>* Other names: with transanal drainage tube;|
| Active Comparator: without TDT<br>without TDT | Procedure: without TDT<br>* After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.<br>* Other names: without transanal drainage tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AL | The primary endpoint was the AL within 30 days after surgery. AL is defined when the following symptoms were noticed: abdominal pain, fever, peritonitis, leukocytosis, procalcitonin (PCT) or c-reactive protein (CRP) increase, discharge of feces, pus, or gas from the drainage or vagina, septicemia with pelvic abscess. All clinically suspicious symptoms were confirmed by digital rectal examination, computed tomography (CT) scan or surgery when necessary. The severity grading of AL was defined according to the International Study Group of Rectal Cancer. In the present study, AL was referred to grade B and C, asymptomatic AL (grade A) was not considered because no active therapeutic intervention was required. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grades of AL | The grades of AL, including grade B, grade C. The severity grading of AL is defined according to the International Study Group of Rectal Cancer | within 30 days after surgery | 
| Postoperative Anal Pain Score | Postoperative pain score. Numerical Rating Scale (NRS) for pains is used to assess the anal postoperative pain score of patients in the TDT group. NRS is the simplest and most commonly used scales for pain evaluation.The numerical scale is most commonly 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. (for the details, please see the literature below FERREIRA-VALENTE M A, PAIS-RIBEIRO J L, JENSEN M P. Validity of four pain intensity rating scales[J]. Pain. 2011, 152(10): 2399-2404) | within 30 days after surgery | 
| Incidence of TDT-related Adverse Events: bleeding | TDT-related adverse events :bleeding | within 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transanal drainage tube, anastomotic leakage, laparoscopic anterior resection, rectal cancer