Prospective and multicenter study on clinical-biological factors predictive of chronic colon diverticulitis: DICRO Trial.

Abstract

Purpose: This manuscript presents the protocol for a prospective, multicenter study aimed at identifying prognostic factors for the recurrence of diverticulitis. The design, methodology, and analysis plan are detailed, providing a comprehensive framework for evaluating clinical endpoints and intervention outcomes in patients with diverticulitis.

Methods: Clinical, observational, prospective, and multicenter study of patients diagnosed with acute diverticulitis in the Emergency Department (ED) of 5 Spanish hospitals. The inclusion criteria were patients with acute diverticulitis who did not require emergency surgery. A 2-year follow-up will be carried out. The main objective is the description of prognostic factors of new episodes of acute diverticulitis and the creation of a therapeutic algorithm to select patients who could benefit from early elective surgery. Secondary endpoints are descriptive analyses of quality of life at different periods to establish the evolution of the disease and to correlate symptoms with systemic and local inflammatory markers; and sub-analysis of immunosuppressed patients to assess disease virulence.

Conclusion: Determination of a marker predictive of recurrent disease or chronic inflammation would be of benefit in developing a good treatment strategy. One group that would particularly benefit is immunosuppressed patients.

Trial registration: ClinicalTrials.gov Identifier: NCT04407793.