27th International Congress of the European Association for Endoscopic Surgery (EAES) Sevilla, Spain, 12–15 June 2019

Abstract

Aims: Infectious complications and anastomotic leakage affect approximately 30% of patients after colorectal cancer surgery. The aim of this multicenter randomized trial was to investigate whether selective decontamination of the digestive tract (SDD) reduces these complications of elective colorectal cancer surgery. Methods: The effectiveness of SDD was evaluated in a multicenter, openlabel, randomised clinical trial in 6 centres in The Netherlands. Patients with colorectal cancer scheduled for elective curative surgery with a primary anastomosis were eligible. Oral colistin, tobramycin, and amphotericin B were administered to the SDD group to decontaminate the digestive tract. Both groups received intravenous cefazoline and metronidazole for peri-operative prophylaxis. Mechanical bowel preparation was given for left sided colectomies, sigmoid and anterior resections. Anastomotic leakage was the primary outcome while infectious complications and mortality were secondary outcomes. This trial was registered with ClinicalTrials.gov number NCT01740947. Results: In total, 228 patients were randomized to the SDD group and 227 to the control group until the trial was stopped after interim-analysis demonstrated that superiority was no longer attainable. Effective SDD was confirmed by interspace DNA profiling analysis of rectal swabs. Anastomotic leakage was observed in 14 patients (6.1%) in the SDD group and in 22 patients (9.6%) in the control group (odds ratio) [OR 0.61 (0.30–1.22)]. In the SDD group, fewer patients had one or more infectious complications than in the control group (14.9% (n = 34) versus 26.9% (n = 61), [OR 0.48 (0.30–0.76)]. On multivariable analysis, SDD reduced infectious complications OR 0.472 (0.294–0.755). Conclusion: SDD reduces infectious complications after colorectal cancer resection but did not significantly reduce anastomotic leakage in this trial. O002—COLORECTAL—Malignant