Background: Anastomotic leakage is the most significant complication after low anterior resection (LAR) for rectal carcinoma, and it is the major cause of postoperative mortality and morbidity. The objective of the present study was to investigate whether the use of a transanal tube as an alternative endoluminal diversion technique for rectal carcinoma can reduce the 30-day leakage rate after LAR.
Methods: From June 2003 to December 2009, a total of 398 patients were randomized to a transanal tube or not after LAR. Inclusion criteria for randomization were biopsy-proven carcinoma of the rectum located ≤15 cm above the anal verge, measured with a rigid rectoscope; age≥18 years; informed consent; ability to understand the study information; estimated survival of >6 months; anterior resection for the lesion; final negative air leakage test; intact anastomotic stapler rings; and the absence of major intraoperative adverse events.
Results: Patient demographics, tumor size and location, Duke's stage, preoperative co-morbidity, and operative details were comparable between the two groups in general analysis and subgroup analysis (double-staple technique and handsewn technique). The overall rate of symptomatic leakage was 6.78% (27 of 398 patients). Patients randomized to a transanal tube (n=200) had leakage in 4.0% (8 of 200 patients) and those without a tube (n=198) in 9.6% (19 of 198 patients) (p=0.026). With regard to the double-staple technique subgroup, 3.7% (7 of 188) patients with a tube presented with a symptomatic anastomotic leakage, compared with 9.3% (17 of 182) of those without a tube (p=0.028). Of the patients with anastomotic leakage in the double-staple technique subgroup, the need for urgent abdominal reoperation was 28.6% (two of seven patients) in those randomized to a transanal tube and 82.4% (14 of 17) in those without (p=0.021). The 30-day mortality after LAR was nil. In the double-staple technique subgroup, a quicker resumption of gastrointestinal motility manifested by a smaller ratio of patients with flatus>postoperative day (POD) 3 (p=0.019) and a smaller ratio of poor gastrointestinal electromyogram on POD 3 (p<0.001) was associated with use of a transanal tube. Additionally, patients with a tube appeared to have a lower rectal resting pressure by POD 3 (4.0±2.2 vs. 5.0±2.2 kPa; p<0.001) or POD 5 (4.3±2.3 vs. 5.6±2.3 kPa; p<0.001), compared to the resting pressures patients without the device, respectively. A shorter length of hospital stay was associated with use of a transanal tube both in the double-staple technique subgroup (p<0.001) and the handsewn technique subgroup (p=0.011). Multivariate logistic regression analysis revealed that body mass index>25 kg/m2 and a poor gastrointestinal electromyogram on POD 3 were found to be independent risk factors for anastomotic leakage in the low anastomosis subgroup.
Conclusions: The presence of a transanal tube is effective and safe in decreasing the rate of clinically significant anastomotic leaks and in mitigating the clinical consequences of leakage after anterior resection for rectal cancer with the technique of total mesorectal excision and double-staple anastomosis. The potential benefits of transanal tube placement are multifactorial, including drainage, reduction of endoluminal pressure, and promotion of gastrointestinal motility. Obesity and poor gastrointestinal electromyogram on POD 3 are independent risk factors for anastomotic leakage in patients with low anastomosis.