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Prospective multicentre cohort trial on acute appendicitis and microbiota, aetiology and effects of antimicrobial treatment: study protocol for the MAPPAC (Microbiology APPendicitis ACuta) trial
- Source :
- BMJ Open
- Publication Year :
- 2019
-
Abstract
- IntroductionBased 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.Methods and analysisMAPPAC 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.Ethics and disseminationThis 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.Trial registration numberNCT03257423
- Subjects :
- medicine.medical_specialty
appendicitis
appendicitisaetiology
medicine.drug_class
Cost-Benefit Analysis
Antibiotics
Administration, Oral
Gastroenterology and Hepatology
030230 surgery
Placebo
Microbiology
03 medical and health sciences
Feces
0302 clinical medicine
Antibiotic resistance
Epidemiology
medicine
Protocol
microbiota
Humans
Multicenter Studies as Topic
030212 general & internal medicine
Prospective Studies
antimicrobial resistance
Finland
business.industry
General Medicine
Length of Stay
medicine.disease
appendectomy
appendicolith
Appendicitis
Anti-Bacterial Agents
Gastrointestinal Microbiome
Clinical trial
Cohort
Acute Disease
Etiology
Administration, Intravenous
business
Tomography, X-Ray Computed
Subjects
Details
- ISSN :
- 20446055
- Volume :
- 9
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- BMJ open
- Accession number :
- edsair.doi.dedup.....95723c252d90da75ba27337955d9572f