The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study

Matteo Origi, Pietro Achilli, Giacomo Calini, Andrea Costanzi, Michela Monteleone, Isacco Montroni, Dario Maggioni, Eugenio Cocozza, Stefano Megna, Mauro Totis, Nicolo' Tamini, Antonio Ziccarelli, Gaetano Filippone, Giovanni Ferrari, Jacopo Crippa, Antonino Spinelli, Giulio M Mari, AIMS Academy Clinical Research Network, Matteo Origi, Pietro Achilli, Giacomo Calini, Andrea Costanzi, Michela Monteleone, Isacco Montroni, Dario Maggioni, Eugenio Cocozza, Stefano Megna, Mauro Totis, Nicolo' Tamini, Antonio Ziccarelli, Gaetano Filippone, Giovanni Ferrari, Jacopo Crippa, Antonino Spinelli, Giulio M Mari, AIMS Academy Clinical Research Network

Abstract

Diverticular disease is an increasingly common issue, with a variety of clinical presentations and treatment options. However, very few prospective cohort studies explore outcomes between the different presentations and treatments. The Diverticular Disease Registry (DDR Trial) is a multicenter, prospective, observational cohort study on behalf of the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. The DDR Trial aims to investigate the short-term postoperative and long-term quality of life outcomes in patients undergoing surgery or medical treatments for diverticular disease. DDR Trial is open to participation by all tertiary-care hospitals. DDR Trial has been registered at ClinicalTrials.gov (NCT04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1st, 2021 and will end after 5 years of recruitment. All adult patients with imaging-proven colonic diverticular disease (i.e., symptomatic colonic diverticulosis including diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease) will be included. The primary outcome of DDR Trial is quality of life assessment at 12-month according to the Gastrointestinal Quality of Life Index (GIQLI). The secondary outcome is 30-day postoperative outcomes according to the Clavien-Dindo classification. DDR Trial will significantly advance in identifying the optimal care for patients with diverticular disease by exploring outcomes of different presentations and treatments.

Highlights: Diverticular disease (i.e., diverticulitis, bleeding) has different treatments.This is a clinical protocol for the Diverticular Disease Registry (DDR Trial).DDR Trial is a multicenter, prospective, observational cohort study open to participation.DDR Trial will study short-term postoperative and long-term quality of life outcomes.Medical treatments, interventional radiology and surgery will be explored.

Keywords: clinical protocols; diverticular disease; diverticulitis; diverticulosis; multicenter study; prospective study.

Conflict of interest statement

The authors have no competing interests to declare.

Copyright: © 2021 The Author(s).

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Source: PubMed

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