University of Oulu

Sippola, S., Grönroos, J., Sallinen, V., Rautio, T., Nordström, P., Rantanen, T., Hurme, S., Leppäniemi, A., Meriläinen, S., Laukkarinen, J., Savolainen, H., Virtanen, J., Salminen, P. (2018). A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol. BMJ Open, 8(11), e023623. https://doi.org/10.1136/bmjopen-2018-023623

A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis : APPAC III trial study protocol

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Author: Sippola, Suvi1,2; Grönroos, Juha1,2; Sallinen, Ville3;
Organizations: 1Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland
2Department of Surgery, University of Turku, Turku, Finland
3Department of Surgery, Helsinki University Central Hospital, Helsinki, Finland
4Department of Surgery, Oulu University Hospital, Oulu, Finland
5Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland
6Department of Surgery, Kuopio University Hospital, Kuopio, Finland
7Department of Biostatistics, University of Turku, Turku, Finland
8Department of Radiology, Turku University Hospital, Turku, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.7 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2019061820957
Language: English
Published: BMJ, 2018
Publish Date: 2019-06-18
Description:

Abstract

Introduction: Recent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking.

Methods and analysis: The APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18–60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals. Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher’s one-sided test and CI will be calculated for proportion difference.

Ethics and dissemination: This protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals.

Trial registration number: NCT03234296; Pre-results

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Series: BMJ open
ISSN: 2044-6055
ISSN-E: 2044-6055
ISSN-L: 2044-6055
Volume: 8
Issue: 11
Article number: e023623
DOI: 10.1136/bmjopen-2018-023623
OADOI: https://oadoi.org/10.1136/bmjopen-2018-023623
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
317 Pharmacy
Subjects:
Funding: This work was supported by the Finnish Society of Digestive Surgeons, which covered the costs of the online database created together with the researchers and BCB Medical. This work was also supported by a government research grant awarded to Turku University Hospital (EVO Foundation) for PS and SS. Additional support from three research grants awarded to both SS (Orion Pharma research foundation and the Finnish Gastroenterological Research Foundation) and PS (Sigrid Juselius Foundation).
Copyright information: © Author(s) (or their employer(s)) 2018.This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.
  https://creativecommons.org/licenses/by-nc/4.0/