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 tekijätSalminen 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

KustantajaOXFORD UNIV PRESS

Julkaisuvuosi2022

JournalBritish Journal of Surgery

Tietokannassa oleva lehden nimiBRITISH JOURNAL OF SURGERY

Lehden akronyymiBRIT J SURG

Volyymi109

Julkaisunumero6

Aloitussivu503

Lopetussivun numero509

Sivujen määrä7

ISSN0007-1323

DOIhttp://dx.doi.org/10.1093/bjs/znac086

Verkko-osoitehttps://doi.org/10.1093/bjs/znac086


Tiivistelmä

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.


Last updated on 2023-16-05 at 13:29