Multicentre, controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics

Abstract

Purpose: Acute diverticulitis (AD) is a highly prevalent disease in Spain. Its chronic-recurrent appearance and high rate of relapse mean that it has a major epidemiological and economic impact on our health system. In spite of this, it has not been studied in any great depth. Reassessing its etiopathology, recent studies have observed that it is an inflammatory disease-not, as classic theories had postulated, an infectious one. In the light of these findings, the suitability of antibiotics for its treatment has been reconsidered. At present, however, the evidence for incorporating these findings into clinical practice guidelines remains insufficient.

Methods: This study was designed to analyse the safety and efficacy of a non-antibiotic treatment for mild AD. Patients with mild AD (grade 0 in the modified Neff classification) who meet the inclusion criteria will be randomly assigned to one of two outpatient treatment strategies: (a) classical treatment (antibiotics, anti-inflammatories and low-fibre diet) or (b) experimental treatment (anti-inflammatories and low-fibre diet). Clinical controls will be performed at 2, 7, 30, and 90 days. We will determine whether there are any differences in the clinical outcome between groups. The main objective is to demonstrate that antibiotics neither accelerate the resolution of the disease nor decrease the number of complications and/or recurrences in these patients, suggesting that their use may be unnecessary.

Conclusions: The results of this trial will help to optimize and homogenize the treatment of this highly prevalent disease. However, more studies are required before firm changes can be introduced in international clinical practice guidelines.

Trial registration: The trial has been registered at the ClinicalTrials.gov database (ID: NCT02785549) and the EU Clinical Trials Register database (EudraCT number: 2016-001596-75).

Keywords: Acute mild diverticulitis; Antibiotic; Inflammatory; Outpatient.