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

L. Daniels; Ünlü; N. de Korte; S. van Dieren; H. B. Stockmann; B. C. Vrouenraets; E. C. Consten; J. A. van der Hoeven; Q. A. Eijsbouts; I. F. Faneyte; W. A. Bemelman; M. G. Dijkgraaf; M. A. Boermeester; C. E M Glaap; A. Croonen; M. A. Cuesta; J. Kuijvenhoven; R. Buijsman; S. Den Uil; P. R. De Reuver; J. B. Tuynman; B. J M Van de Wall; M. A W Stam; R. M H Roumen; W. Truin; R. Wijn; M. F. Gerhards; K. F D Kuhlmann; E. S. Van der Zaag; J. E. Biemond; R. J. Klicks; N. Dhar; H. A. Cense; G. H. De Groot; Y. Pikoulin; G. H. Van Ramshorst; L. L. Hoornweg; L. Koet; A. A W Van Geloven; M. Emous; A. T P M Claassen; S. Mollink; D. J A Sonneveld; L. Bouvé; G. M P Diepenhorst; W. J. Vles; B. R. Toorenvliet; J. F. Lange; G. H H Mannaerts; B. A. Grotenhuis; R. J De Vos tot Nederveen Cappel; E. B. Deerenberg; A. C T M Depla; S. Bruin; X. Vos; J. J G Scheepers; M. J. Boom; D. Boerma; S. Van Esser; J. Pruim; J. B. Reitsma

doi:10.1002/bjs.10309

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

L. Daniels^*, Ünlü, N. de Korte, S. van Dieren, H. B. Stockmann, B. C. Vrouenraets, E. C. Consten, J. A. van der Hoeven, Q. A. Eijsbouts, I. F. Faneyte, W. A. Bemelman, M. G. Dijkgraaf, M. A. Boermeester, C. E M Glaap, A. Croonen, M. A. Cuesta, J. Kuijvenhoven, R. Buijsman, S. Den Uil, P. R. De ReuverJ. B. Tuynman, B. J M Van de Wall, M. A W Stam, R. M H Roumen, W. Truin, R. Wijn, M. F. Gerhards, K. F D Kuhlmann, E. S. Van der Zaag, J. E. Biemond, R. J. Klicks, N. Dhar, H. A. Cense, G. H. De Groot, Y. Pikoulin, G. H. Van Ramshorst, L. L. Hoornweg, L. Koet, A. A W Van Geloven, M. Emous, A. T P M Claassen, S. Mollink, D. J A Sonneveld, L. Bouvé, G. M P Diepenhorst, W. J. Vles, B. R. Toorenvliet, J. F. Lange, G. H H Mannaerts, B. A. Grotenhuis, R. J De Vos tot Nederveen Cappel, E. B. Deerenberg, A. C T M Depla, S. Bruin, X. Vos, J. J G Scheepers, M. J. Boom, D. Boerma, S. Van Esser, J. Pruim, J. B. Reitsma

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 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).

Original language	English
Pages (from-to)	52-61
Number of pages	10
Journal	British Journal of Surgery
Volume	104
Issue number	1
DOIs	https://doi.org/10.1002/bjs.10309
Publication status	Published - Jan 2017

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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., ... Reitsma, J. B. (2017). Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis. British Journal of Surgery, 104(1), 52-61. https://doi.org/10.1002/bjs.10309

@article{46f5f08f485148ad936d67596ff51397,

title = "Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis",

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 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).",

author = "L. Daniels and {\"U}nl{\"u} and {de Korte}, N. and {van Dieren}, S. and Stockmann, {H. B.} and Vrouenraets, {B. C.} and Consten, {E. C.} and {van der Hoeven}, {J. A.} and Eijsbouts, {Q. A.} and Faneyte, {I. F.} and Bemelman, {W. A.} and Dijkgraaf, {M. G.} and Boermeester, {M. A.} and Glaap, {C. E M} and A. Croonen and Cuesta, {M. A.} and J. Kuijvenhoven and R. Buijsman and {Den Uil}, S. and {De Reuver}, {P. R.} and Tuynman, {J. B.} and {Van de Wall}, {B. J M} and Stam, {M. A W} and Roumen, {R. M H} and W. Truin and R. Wijn and Gerhards, {M. F.} and Kuhlmann, {K. F D} and {Van der Zaag}, {E. S.} and Biemond, {J. E.} and Klicks, {R. J.} and N. Dhar and Cense, {H. A.} and {De Groot}, {G. H.} and Y. Pikoulin and {Van Ramshorst}, {G. H.} and Hoornweg, {L. L.} and L. Koet and {Van Geloven}, {A. A W} and M. Emous and Claassen, {A. T P M} and S. Mollink and Sonneveld, {D. J A} and L. Bouv{\'e} and Diepenhorst, {G. M P} and Vles, {W. J.} and Toorenvliet, {B. R.} and Lange, {J. F.} and Mannaerts, {G. H H} and Grotenhuis, {B. A.} and {tot Nederveen Cappel}, {R. J De Vos} and Deerenberg, {E. B.} and Depla, {A. C T M} and S. Bruin and X. Vos and Scheepers, {J. J G} and Boom, {M. J.} and D. Boerma and {Van Esser}, S. and J. Pruim and Reitsma, {J. B.}",

note = "Funding Information: The authors thank the patients who participated in the study, members of the DSMB (P. Bossuyt, Chair; H. Gooszen; J. van der Meer) and investigators, coordinators, clinicians and (research) nurses. The DIABOLO trial was funded by the Netherlands Organization for Health Research and Development (ZonMw; 171002303) and the Digestive Diseases Foundation (Maag Lever Darm Stichting, MLDS WO08-54). The funders had no involvement in trial design, conduct or reporting. Disclosure: The authors declare no conflict of interest. Publisher Copyright: {\textcopyright} 2016 BJS Society Ltd Published by John Wiley & Sons Ltd",

year = "2017",

month = jan,

doi = "10.1002/bjs.10309",

language = "English",

volume = "104",

pages = "52--61",

journal = "British Journal of Surgery",

issn = "0007-1323",

publisher = "John Wiley & Sons Inc.",

number = "1",

}

Daniels, L, Ünlü, de Korte, N, van Dieren, S, Stockmann, HB, Vrouenraets, BC, Consten, EC, van der Hoeven, JA, Eijsbouts, QA, Faneyte, IF, Bemelman, WA, Dijkgraaf, MG, Boermeester, MA, Glaap, CEM, Croonen, A, Cuesta, MA, Kuijvenhoven, J, Buijsman, R, Den Uil, S, De Reuver, PR, Tuynman, JB, Van de Wall, BJM, Stam, MAW, Roumen, RMH, Truin, W, Wijn, R, Gerhards, MF, Kuhlmann, KFD, Van der Zaag, ES, Biemond, JE, Klicks, RJ, Dhar, N, Cense, HA, De Groot, GH, Pikoulin, Y, Van Ramshorst, GH, Hoornweg, LL, Koet, L, Van Geloven, AAW, Emous, M, Claassen, ATPM, Mollink, S, Sonneveld, DJA, Bouvé, L, Diepenhorst, GMP, Vles, WJ, Toorenvliet, BR, Lange, JF, Mannaerts, GHH, Grotenhuis, BA, tot Nederveen Cappel, RJDV, Deerenberg, EB, Depla, ACTM, Bruin, S, Vos, X, Scheepers, JJG, Boom, MJ, Boerma, D, Van Esser, S, Pruim, J & Reitsma, JB 2017, 'Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis', British Journal of Surgery, vol. 104, no. 1, pp. 52-61. https://doi.org/10.1002/bjs.10309

TY - JOUR

T1 - Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis

AU - Daniels, L.

AU - Ünlü,

AU - de Korte, N.

AU - van Dieren, S.

AU - Stockmann, H. B.

AU - Vrouenraets, B. C.

AU - Consten, E. C.

AU - van der Hoeven, J. A.

AU - Eijsbouts, Q. A.

AU - Faneyte, I. F.

AU - Bemelman, W. A.

AU - Dijkgraaf, M. G.

AU - Boermeester, M. A.

AU - Glaap, C. E M

AU - Croonen, A.

AU - Cuesta, M. A.

AU - Kuijvenhoven, J.

AU - Buijsman, R.

AU - Den Uil, S.

AU - De Reuver, P. R.

AU - Tuynman, J. B.

AU - Van de Wall, B. J M

AU - Stam, M. A W

AU - Roumen, R. M H

AU - Truin, W.

AU - Wijn, R.

AU - Gerhards, M. F.

AU - Kuhlmann, K. F D

AU - Van der Zaag, E. S.

AU - Biemond, J. E.

AU - Klicks, R. J.

AU - Dhar, N.

AU - Cense, H. A.

AU - De Groot, G. H.

AU - Pikoulin, Y.

AU - Van Ramshorst, G. H.

AU - Hoornweg, L. L.

AU - Koet, L.

AU - Van Geloven, A. A W

AU - Emous, M.

AU - Claassen, A. T P M

AU - Mollink, S.

AU - Sonneveld, D. J A

AU - Bouvé, L.

AU - Diepenhorst, G. M P

AU - Vles, W. J.

AU - Toorenvliet, B. R.

AU - Lange, J. F.

AU - Mannaerts, G. H H

AU - Grotenhuis, B. A.

AU - tot Nederveen Cappel, R. J De Vos

AU - Deerenberg, E. B.

AU - Depla, A. C T M

AU - Bruin, S.

AU - Vos, X.

AU - Scheepers, J. J G

AU - Boom, M. J.

AU - Boerma, D.

AU - Van Esser, S.

AU - Pruim, J.

AU - Reitsma, J. B.

N1 - Funding Information: The authors thank the patients who participated in the study, members of the DSMB (P. Bossuyt, Chair; H. Gooszen; J. van der Meer) and investigators, coordinators, clinicians and (research) nurses. The DIABOLO trial was funded by the Netherlands Organization for Health Research and Development (ZonMw; 171002303) and the Digestive Diseases Foundation (Maag Lever Darm Stichting, MLDS WO08-54). The funders had no involvement in trial design, conduct or reporting. Disclosure: The authors declare no conflict of interest. Publisher Copyright: © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd

PY - 2017/1

Y1 - 2017/1

N2 - 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. 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).

AB - 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. 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).

UR - http://www.scopus.com/inward/record.url?scp=84994891143&partnerID=8YFLogxK

U2 - 10.1002/bjs.10309

DO - 10.1002/bjs.10309

M3 - Article

C2 - 27686365

AN - SCOPUS:84994891143

SN - 0007-1323

VL - 104

SP - 52

EP - 61

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 1

ER -

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

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