Safety profile of a multimodal fail-safe model to minimize postoperative complications in oncologic colorectal resections-a cohort study.

BACKGROUND

Despite innovations in surgical techniques, major complications following colorectal surgery still lead to a significant morbidity and mortality. There is no standard protocol for perioperative management of patients with colorectal cancer. This study evaluates the effectiveness of a multimodal fail-safe model in minimizing severe surgical complications following colorectal resections.

METHODS

We compared major complications in patients with colorectal cancers who underwent surgical resections with anastomosis during 2013-2014 (control group) with patients treated during 2015-2019 (fail-safe group). The fail-safe group had preoperative bowel preparation and a perioperative single dose of antibiotics, on-table bowel irrigation and early sigmoidoscopic assessment of anastomosis in rectal resections. A standard surgical technique for tension-free anastomosis was adapted in the fail-safe approach. The chi-square test measured relationships between categorical variables, t-test estimated the probability of differences, and the multivariate regression analysis determined the linear correlation among independent and dependent variables.

RESULTS

A total of 924 patients underwent colorectal operations during the study period; however, 696 patients had surgical resections with primary anastomoses. There were 427 (61.4%) laparoscopic and 230 (33.0%) open operations, while 39 (5.6%) laparoscopic procedures were converted. Overall, the rate of major complications (Dindo-Clavien grade IIIb-V) significantly reduced from 22.6% for the control group to 9.8% for the fail-safe group (p < 0.0001). Major complications mainly occurred due to non-surgical reasons such as pneumonia, heart failure, or renal dysfunction. The rates of anastomotic leakage (AL) were 11.8% (22/186) and 3.7% (n = 19/510) for the control and fail-safe groups, respectively (p < 0.0001).

CONCLUSION

We report an effective multimodal fail-safe protocol for colorectal cancer during the pre-, peri-, and postoperative period. The fail-safe model showed less postoperative complications even for low rectal anastomosis. This approach can be adapted as a structured protocol during the perioperative care of patients for colorectal surgery.

TRIAL REGISTRATION

This study was registered in the German Clinical Trial Register (Study ID: DRKS00023804 ).