Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis.
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 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.


CONCLUSIONS
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).
Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
L
L
Daniels
Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.|Departments of Surgery, Medical Centre Alkmaar, Alkmaar, The Netherlands.
Ç
Ç
Ünlü
Spaarne Gasthuis Hospital, Hoofddorp, The Netherlands.
N
N
de Korte
Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
S
S
van Dieren
Spaarne Gasthuis Hospital, Haarlem, The Netherlands.
H B
HB
Stockmann
Department of Surgery, Onze Lieve Vrouwe Gasthuis West, Amsterdam, The Netherlands.
B C
BC
Vrouenraets
Meander Medical Centre, Amersfoort, The Netherlands.
E C
EC
Consten
Albert Schweitzer Hospital, Dordrecht, The Netherlands.
J A
JA
van der Hoeven
Spaarne Gasthuis Hospital, Hoofddorp, The Netherlands.
Q A
QA
Eijsbouts
Ziekenhuisgroep Twente Hospital, Almelo, The Netherlands.
I F
IF
Faneyte
Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
W A
WA
Bemelman
Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
M G
MG
Dijkgraaf
Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
M A
MA
Boermeester
D000208:Acute Disease; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D012809:Colon, Sigmoid / Q000601:surgery; D004239:Diverticulitis, Colonic / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D010359:Patient Readmission / Q000706:statistics & numerical data; D020127:Recovery of Function; D014057:Tomography, X-Ray Computed; D064232:Visual Analog Scale; D057832:Watchful Waiting
D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination