Prospective multicentre cohort trial on acute appendicitis and microbiota, aetiology and effects of antimicrobial treatment: study protocol for the MAPPAC (Microbiology APPendicitis ACuta) trial.
Acute Disease
Administration, Intravenous
Administration, Oral
Anti-Bacterial Agents
/ administration & dosage
Appendectomy
Appendicitis
/ diagnostic imaging
Cost-Benefit Analysis
Feces
/ microbiology
Finland
Gastrointestinal Microbiome
/ drug effects
Humans
Length of Stay
Multicenter Studies as Topic
Prospective Studies
Tomography, X-Ray Computed
antimicrobial resistance
appendectomy
appendicitis
appendicitisaetiology
appendicolith
microbiota
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
06 09 2019
06 09 2019
Historique:
entrez:
9
9
2019
pubmed:
9
9
2019
medline:
9
10
2020
Statut:
epublish
Résumé
Based on the epidemiological and clinical data, acute appendicitis can present either as uncomplicated or complicated. The aetiology of these different appendicitis forms remains unknown. Antibiotic therapy has been shown to be safe, efficient and cost-effective for CT-confirmed uncomplicated acute appendicitis. Despite appendicitis being one of the most common surgical emergencies, there are very few reports on appendicitis aetiology and pathophysiology focusing on the differences between uncomplicated and complicated appendicitis. Microbiology APPendicitis ACuta (MAPPAC) trial aims to evaluate these microbiological and immunological aspects including immune response in the aetiology of these different forms also assessing both antibiotics non-responders and appendicitis recurrence. In addition, MAPPAC aims to determine antibiotic and placebo effects on gut microbiota composition and antimicrobial resistance. MAPPAC is a prospective clinical trial with both single-centre and multicentre arm conducted in close synergy with concurrent trials APPendicitis ACuta II (APPAC II) (per oral (p.o.) vs intravenous+p.o. antibiotics, NCT03236961) and APPAC III (double-blind trial placebo vs antibiotics, NCT03234296) randomised clinical trials. Based on the enrolment for these trials, patients with CT-confirmed uncomplicated acute appendicitis are recruited also to the MAPPAC study. In addition to these conservatively treated randomised patients with uncomplicated acute appendicitis, MAPPAC will recruit patients with uncomplicated and complicated appendicitis undergoing appendectomy. Rectal and appendiceal swabs, appendicolith, faecal and serum samples, appendiceal biopsies and clinical data are collected during the hospital stay for microbiological and immunological analyses in both study arms with the longitudinal study arm collecting faecal samples also during follow-up up to 12 months after appendicitis treatment. This study has been approved by the Ethics Committee of the Hospital District of Southwest Finland (Turku University Hospital, approval number ATMK:142/1800/2016) and the Finnish Medicines Agency. Results of the trial will be published in peer-reviewed journals. NCT03257423.
Identifiants
pubmed: 31494621
pii: bmjopen-2019-031137
doi: 10.1136/bmjopen-2019-031137
pmc: PMC6731800
doi:
Substances chimiques
Anti-Bacterial Agents
0
Banques de données
ClinicalTrials.gov
['NCT03257423']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e031137Investigateurs
V Sallinen
(V)
A Leppäniemi
(A)
T Rautio
(T)
S Meriläinen
(S)
P Nordström
(P)
J Laukkarinen
(J)
T Rantala
(T)
H Savolainen
(H)
M Aarnio
(M)
A Mattila
(A)
J Haijanen
(J)
E-L Sävelä
(EL)
I Imre
(I)
H Paajanen
(H)
J Rintala
(J)
T Pinta
(T)
T Sippola
(T)
P Böckerman
(P)
Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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