Vertaisarvioitu alkuperäisartikkeli tai data-artikkeli tieteellisessä aikakauslehdessä (A1)
Antibiotics versus placebo in adults with CT-confirmed uncomplicated acute appendicitis (APPAC III): randomized double-blind superiority trial
Julkaisun tekijät: Salminen Paulina, Sippola Suvi, Haijanen Jussi, Nordström Pia, Rantanen Tuomo, Rautio Tero, Sallinen Ville, Löyttyniemi Eliisa, Hurme Saija, Tammilehto Ville, Laukkarinen Johanna, Savolainen Heini, Meriläinen Sanna, Leppäniemi Ari, Grönroos Juha
Kustantaja: OXFORD UNIV PRESS
Julkaisuvuosi: 2022
Journal: British Journal of Surgery
Tietokannassa oleva lehden nimi: BRITISH JOURNAL OF SURGERY
Lehden akronyymi: BRIT J SURG
Volyymi: 109
Julkaisunumero: 6
Aloitussivu: 503
Lopetussivun numero: 509
Sivujen määrä: 7
ISSN: 0007-1323
DOI: http://dx.doi.org/10.1093/bjs/znac086
Verkko-osoite: https://doi.org/10.1093/bjs/znac086
Background: Non-operative management of uncomplicated acute appendicitis is an option, but omission of antibiotics from the regimen has not been tested.
Methods: A double-blind, placebo-controlled, superiority RCT in adults with CT-confirmed uncomplicated acute appendicitis was designed to compare placebo with antibiotics (intravenous ertapenem followed by oral levofloxacin and metronidazole). The primary endpoint was treatment success (resolution resulting in discharge without appendicectomy within 10 days); secondary outcomes included pain scores, complications, hospital stay, and return to work.
Results: From May 2017 to September 2020, 72 patients with a mean(s.d.) age of 37.5 (11.1) years were recruited at five hospitals. Six were excluded after randomization (5 early consent withdrawals, 1 randomization protocol violation), 35 were assigned to receive antibiotics, and 31 to receive placebo. Enrolment challenges (including hospital pharmacy resources in an acute-care surgery setting) meant that only the lowest sample size of three predefined scenarios was achieved. The 10-day treatment success rate was 87 (95 per cent c.i. 75 to 99) per cent for placebo and 97 (92 to 100) per cent for antibiotics. This clinical difference of 10 (90 per cent c.i. -0.9 to 21) per cent was not statistically different for the primary outcome (1-sided P = 0.142), and secondary outcomes were similar.
Conclusion: The lack of antibiotic superiority statistically suggests that a non-inferiority trial against placebo is warranted in adults with CT-confirmed mild appendicitis.