[Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial].

OBJECTIVE: To investigate the effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer.

METHODS: In this study, 300 patients diagnosed with rectal cancer, scheduled to undergo laparoscopic anterior resection at the Department of Gastrointestinal Surgery of Anhui Provincial Hospital, between September 2014 and December 2016, were prospectively enrolled. Patients were randomly assigned to undergo laparoscopic rectal resection with (reinforcing group, n=150) or without (control group, n=150) anastomotic reinforcing sutures. The laparoscopic total mesorectal excision was followed for all patients. In the reinforcing group, 4-0 absorbable sutures were used to reinforce the 2-4 needles used for the 2 cross-cutting lines that formed the stapler. Concurrent obstructions; the need for hemorrhagic emergency surgery, preventive ileostomy, Hartmann operation, abdominoperineal resection, or open surgery; and the presence of unresectable cancer were all reasons for excluding patients from the study. Univariate and multivariate analyses were performed on the clinical data collected for the two groups. According to the multivariate analysis results, patients were further divided into high-risk(≥2 high risk factors) and low-risk (≤1 high risk factor) groups, and were stratified to analyze the relationship between reinforcing suture use and the incidence of anastomotic leakage. This trial, approved by the Ethics Committee of Anhui Provincial Hospital, was registered as NCT02830633.

RESULTS: A total of 291 patients were included in the study, namely 145 in the reinforcing group and 146 in the control group. There were no significant differences between the two groups with respect to their general data or intra-operative conditions(all P>0.05). The overall incidence of anastomotic leakage was 7.6%(22/291); 3.4%(5/145) in the reinforcing group and 11.6% (17/146) in the control group(χ2 =6.992, P=0.008). Multivariate analyses showed that the lack of reinforcing sutures was an independent risk factor for anastomotic leakage (OR=2.75; 95%CI, 1.72-5.48; P=0.014). Other independent risk factors included NRS2002 score ≥3 points, tumor diameter ≥4 cm, and tumor to anal margin distance <5 cm. There were 80 patients in the high-risk group and 211 in the low-risk group, based on the aforementioned 3 risk factors. The incidence of anastomotic leakage was 27.1%(13/48) among the control patients in the high-risk group, but only 6.2% (2/32) among high-risk patients receiving reinforcing anastomotic sutures(χ2 =5.470, P=0.019). In the low-risk group, the incidence of anastomotic leakage was 2.7%(3/113) among patients receiving reinforcing anastomotic sutures, and 4.1%(4/98) among those not receiving reinforcing sutures. No significant difference was observed (χ2 =0.333, P=0.564).

CONCLUSION: Anastomotic reinforcing sutures for the prevention of anastomotic leakage after laparoscopic radical resection of rectal cancer is convenient and effective, particularly for patients with multiple risk factors.