Primary anastomosis vs nonrestorative resection for perforated diverticulitis with peritonitis: a prematurely terminated randomized controlled trial

Abstract Aim This randomized controlled trial (RCT) was per-formed to test the hypothesis that adverse event ratesfollowing primary anastomosis (PRA) are not inferior tothose following nonrestorative colon resection for perfo-rated diverticulitis with peritonitis.Method Patients admitted for perforated diverticulitiswith peritonitis were randomly assigned to PRA (leftcolon resection with PRA and loop ileostomy) ornonrestorative colon resection (left colon resection withend colostomy). The endpoint was adverse events definedas mortality and morbidity following PRA or nonrestor-ative colon resection and stoma reversal. The estimatedsample size was 300 patients in each study arm (alpha0.10; 90% power).Results During a 9-year period, 90 patients wererandomly assigned to undergo PRA or nonrestorativecolon resection in 14 centres in eight countries. Thirty-four PRA patients were comparable to 56 nonrestorativecolon resection patients for age (P = 0.481), gender(P = 0.190), APACHE III (P = 0.281), Hinchey stageIII vs IV (P = 0.394) and Mannheim Peritonitis Index(P = 0.145). There were no differences in operating time(P = 0.231), surgeries performed at night (P = 0.083),open vs laparoscopic approach (P = 0.419) and litres ofperitoneal irrigation (P = 0.096). There was no signifi-cant difference in mortality (2.9 vs 10.7%; P = 0.247)and morbidity (35.3 vs 46.4%; P = 0.38) following PRAor nonrestorative colon resection. After a similar lag time(P = 0.43), 64.7% of PRA patients and 60% of nonre-storative colon resection patients underwent stomareversal (P = 0.659). Adverse event rates followingstoma reversal differed significantly after PRA andreversal of nonrestorative resection (4.5 vs 23.5%;P = 0.0589).Conclusion No conclusions may be drawn on preferenceof one treatment over another from this RCT because itwas prematurely terminated following accrual of 15% ofits sample size.Keywords Nonrestorative resection, perforated diverti-culitis, peritonitis, primary anastomosis, randomizedcontrolled trialWhat is new in this paper?A randomized controlled trial comparing primary anas-tomosis with nonrestorative colon resection for perfo-rated diverticulitis with peritonitis is practicallyunfeasible. Using mortality as an endpoint entails a largesample size which requires a multicentre design. Thereare insurmountable difficulties inherent with emergencysurgery research for life-threatening conditions.