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(Journal Article) |
《British Journal of Surgery》 104 (2017)
Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT‐proven uncomplicated acute diverticulitis
L Daniels
,
& Uuml;Nlü
,
De Korte
,
Van Dieren
,
HB Stockmann
ABSTRACT
BackgroundAntibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis.MethodsPatients with CT‐proven, primary, left‐sided, uncomplicated, acute diverticulitis were included at 22 clinical sites in the Netherlands, and assigned randomly to an observational or antibiotic treatment strategy. The primary endpoint was time to recovery during 6 months of follow‐up. Main secondary endpoints were readmission rate, complicated, ongoing and recurrent diverticulitis, sigmoid resection and mortality. Intention‐to‐treat and per‐protocol analyses were done.ResultsA total of 528 patients were included. Median time to recovery was 14 (i.q.r. 6–35) days for the observational and 12 (7–30) days for the antibiotic treatment strategy, with a hazard ratio for recovery of 0·91 (lower limit of 1‐sided 95 per cent c.i. 0·78; P = 0·151). No significant differences between the observation and antibiotic treatment groups were found for secondary endpoints: complicated diverticulitis (3·8 versus 2·6 per cent respectively; P = 0·377), ongoing diverticulitis (7·3 versus 4·1 per cent; P = 0·183), recurrent diverticulitis (3·4 versus 3·0 per cent; P = 0·494), sigmoid resection (3·8 versus 2·3 per cent; P = 0·323), readmission (17·6 versus 12·0 per cent; P = 0·148), adverse events (48·5 versus 54·5 per cent; P = 0·221) and mortality (1·1 versus 0·4 per cent; P = 0·432). Hospital stay was significantly shorter in the observation group (2 versus 3 days; P = 0·006). Per‐protocol analyses were concordant with the intention‐to‐treat analyses.ConclusionObservational treatment without antibiotics did not prolong recovery and can be considered appropriate in patients with uncomplicated diverticulitis. Registration number: NCT01111253 (http://www.clinicaltrials.gov).