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