Mortality risk analysis following routine vs selective defunctioning stoma formation after total mesorectal excision for rectal cancer

Abstract

Objective To answer the question whether a defunctioning stoma (DS) should be constructed routinely after total mesorectal excision or whether it could be used selectively to ensure patient safety. Method A PubMed search was performed. All randomized trials on the role of a DS were included. Also, observational articles published between January 1997 and August 2007 were reviewed. Sensitivity analysis of the mortality risk was performed. Results The clinical anastamotic leak (CAL) rate was 17% in 358 patients from four randomized trials and 9.6% in 4059 patients from 39 observational studies. The CAL rate increased significantly from 9.6% with DS to 24.4% without DS in four randomized trials, and from 7.9% with DS to 13.2% without DS in 17 observational studies. The re-operation rate as a result of anastomotic leakage was lower in patients with DS than in patients without DS in both study types. Leak-related mortality was not significantly different: 7.2% with vs 7.7% without DS in observational studies, and 0% with vs 4.6% without DS in randomized trials. Sensitivity analysis indicated that a selective DS strategy is acceptable if the CAL rate without DS is less than 16.6% with a CAL-related mortality of no more than 4.6%. Conclusion The results of this review support the routine construction of a protective stoma. However, selective use of a DS is justified from a patient safety point of view if the CAL-rate and its related mortality are limited. Each unit should audit its performance.