Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis
Daniels, L.; Ünlü; de Korte, N.; van Dieren, S.; Stockmann, H. B.; Vrouenraets, B. C.; Consten, E. C.; van der Hoeven, J. A.; Eijsbouts, Q. A.; Faneyte, I. F.; Bemelman, W. A.; Dijkgraaf, M. G.; Boermeester, M. A.; Glaap, C. E M; Croonen, A.; Cuesta, M. A.; Kuijvenhoven, J.; Buijsman, R.; Den Uil, S.; De Reuver, P. R.; Tuynman, J. B.; Van de Wall, B. J M; Stam, M. A W; Roumen, R. M H; Truin, W.; Wijn, R.; Gerhards, M. F.; Kuhlmann, K. F D; Van der Zaag, E. S.; Biemond, J. E.; Klicks, R. J.; Dhar, N.; Cense, H. A.; De Groot, G. H.; Pikoulin, Y.; Van Ramshorst, G. H.; Hoornweg, L. L.; Koet, L.; Van Geloven, A. A W; Emous, M.; Claassen, A. T P M; Mollink, S.; Sonneveld, D. J A; Bouvé, L.; Diepenhorst, G. M P; Vles, W. J.; Toorenvliet, B. R.; Lange, J. F.; Mannaerts, G. H H; Grotenhuis, B. A.; tot Nederveen Cappel, R. J De Vos; Deerenberg, E. B.; Depla, A. C T M; Bruin, S.; Vos, X.; Scheepers, J. J G; Boom, M. J.; Boerma, D.; Van Esser, S.; Pruim, J.; Reitsma, J. B.
(2017) British Journal of Surgery, volume 104, issue 1, pp. 52 - 61
(Article)
Abstract
Background: Antibiotics 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. Methods: Patients with CT-proven, primary, left-sided, uncomplicated, acute diverticulitis were
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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. Results: A 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. Conclusion: Observational treatment without antibiotics did not prolong recovery and can be considered appropriate in patients with uncomplicated diverticulitis. Registration number: NCT01111253 (http://www.clinicaltrials.gov).
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Keywords: Surgery, Journal Article, Multicenter Study, Pragmatic Clinical Trial, Randomized Controlled Trial
ISSN: 0007-1323
Publisher: John Wiley and Sons Ltd
(Peer reviewed)