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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

Authors: Anne Loes van den Boom, Elisabeth M. L. de Wijkerslooth, Joost van Rosmalen, Frédérique H. Beverdam, Evert-Jan G. Boerma, Marja A. Boermeester, Joanna W. A. M. Bosmans, Thijs A. Burghgraef, Esther C. J. Consten, Imro Dawson, Jan Willem T. Dekker, Marloes Emous, Anna A. W. van Geloven, Peter M. N. Y. H. Go, Luc A. Heijnen, Sander A. Huisman, Dayanara Jean Pierre, Joske de Jonge, Jurian H. Kloeze, Marc A. Koopmanschap, Hester R. Langeveld, Misha D. P. Luyer, Damian C. Melles, Johan W. Mouton, Augustinus P. T. van der Ploeg, Floris B. Poelmann, Jeroen E. H. Ponten, Charles C. van Rossem, Wilhelmina H. Schreurs, Joël Shapiro, Pascal Steenvoorde, Boudewijn R. Toorenvliet, Joost Verhelst, Hendt P. Versteegh, Rene M. H. Wijnen, Bas P. L. Wijnhoven

Published in: Trials | Issue 1/2018

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Abstract

Background

Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days.

Methods

Patients of 8 years and older undergoing appendectomy for acute complex appendicitis – defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess – are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed.

Discussion

This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly.

Trial registration

Dutch Trial Register, NTR6128. Registered on 20 December 2016.
Appendix
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Metadata
Title
Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial
Authors
Anne Loes van den Boom
Elisabeth M. L. de Wijkerslooth
Joost van Rosmalen
Frédérique H. Beverdam
Evert-Jan G. Boerma
Marja A. Boermeester
Joanna W. A. M. Bosmans
Thijs A. Burghgraef
Esther C. J. Consten
Imro Dawson
Jan Willem T. Dekker
Marloes Emous
Anna A. W. van Geloven
Peter M. N. Y. H. Go
Luc A. Heijnen
Sander A. Huisman
Dayanara Jean Pierre
Joske de Jonge
Jurian H. Kloeze
Marc A. Koopmanschap
Hester R. Langeveld
Misha D. P. Luyer
Damian C. Melles
Johan W. Mouton
Augustinus P. T. van der Ploeg
Floris B. Poelmann
Jeroen E. H. Ponten
Charles C. van Rossem
Wilhelmina H. Schreurs
Joël Shapiro
Pascal Steenvoorde
Boudewijn R. Toorenvliet
Joost Verhelst
Hendt P. Versteegh
Rene M. H. Wijnen
Bas P. L. Wijnhoven
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2629-0

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