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. 2018 Dec 17;18(1):117.
doi: 10.1186/s12893-018-0451-y.

Optimising the antibiotic treatment of uncomplicated acute appendicitis: a protocol for a multicentre randomised clinical trial (APPAC II trial)

J Haijanen  1   2   3 , S Sippola  1   2 , J Grönroos  1   2 , T Rautio  4 , P Nordström  5 , T Rantanen  6   7 , M Aarnio  8 , I Ilves  9 , S Hurme  10 , H Marttila  11 , J Virtanen  12 , A Mattila  8 , H Paajanen  9   13 , P Salminen  14   15 ; APPAC study group
Collaborators, Affiliations

Optimising the antibiotic treatment of uncomplicated acute appendicitis: a protocol for a multicentre randomised clinical trial (APPAC II trial)

J Haijanen et al. BMC Surg. .

Abstract

Background: Based on epidemiological and clinical data acute appendicitis can present either as uncomplicated (70-80%) or complicated (20-30%) disease. Recent studies have shown that antibiotic therapy is both safe and cost-effective for a CT-scan confirmed uncomplicated acute appendicitis. However, based on the study protocols to ensure patient safety, these randomised studies used mainly broad-spectrum intravenous antibiotics requiring additional hospital resources and prolonged hospital stay. As we now know that antibiotic therapy for uncomplicated acute appendicitis is feasible and safe, further studies evaluating optimisation of the antibiotic treatment regarding both antibiotic spectrum and shorter hospital stay are needed to evaluate antibiotics as the first-line treatment for uncomplicated acute appendicitis.

Methods: APPAC II trial is a multicentre, open-label, non-inferiority randomised controlled trial comparing per oral (p.o.) antibiotic monotherapy with intravenous (i.v.) antibiotic therapy followed by p.o. antibiotics in the treatment of CT-scan confirmed uncomplicated acute appendicitis. Adult patients with CT-scan diagnosed uncomplicated acute appendicitis will be enrolled in nine Finnish hospitals. The intended sample size is 552 patients. Primary endpoint is the success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during one-year follow-up. Secondary endpoints include post-intervention complications, late recurrence of acute appendicitis after one year, duration of hospital stay, pain, quality of life, sick leave and treatment costs. Primary endpoint will be evaluated in two stages: point estimates with 95% confidence interval (CI) will be calculated for both groups and proportion difference between groups with 95% CI will be calculated and evaluated based on 6 percentage point non-inferiority margin.

Discussion: To our knowledge, APPAC II trial is the first randomised controlled trial comparing per oral antibiotic monotherapy with intravenous antibiotic therapy continued by per oral antibiotics in the treatment of uncomplicated acute appendicitis. The APPAC II trial aims to add clinical evidence on the debated role of antibiotics as the first-line treatment for a CT-confirmed uncomplicated acute appendicitis as well as to optimise the non-operative treatment for uncomplicated acute appendicitis.

Trial registration: Clinicaltrials.gov , NCT03236961, retrospectively registered on the 2nd of August 2017.

Keywords: Acute appendicitis; Antibiotic therapy; Appendicitis; Low-dose CT; Non-operative treatment; Uncomplicated appendicitis.

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Conflict of interest statement

Ethics approval and consent to participate

This protocol has been accepted by the Ethical Committee of Turku University Hospital district and Finnish Medicines Agency (Fimea). The trial will be conducted in compliance with the Declaration of Helsinki. All patients participating in the study will give written consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
APPAC II flow diagram
See this image and copyright information in PMC

References

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