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,Andrea Costanzi,Pietro Achilli,Stefano Megna,Isacco Montroni,Mauro Totis,Nicolo’ Tamini,Giacomo Calini,Eugenio Cocozza,Antonino Spinelli,Dario Maggioni,Antonio Ziccarelli,Michela Monteleone,Gaetano Filippone,Giovanni Ferrari,Jacopo Crippa,Giulio M Mari

doi:10.29337/ijsp.157

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 (NCT 04907383). 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.HighlightsDiverticular 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.

Highlights

Diverticular Disease (DD) is defined as clinically significant and symptomatic colonic diverticulosis and includes diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease (SUDD) [1]
Initial experiences of registry on DD recently appeared in the literature [16,17,18], suggesting the genesis of networks dedicated to DD as the best feasible way to strengthen clinical evidence
The DDR Trial is open to participation by all tertiary-care hospitals

Summary

Introduction

Diverticular Disease (DD) is defined as clinically significant and symptomatic colonic diverticulosis and includes diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease (SUDD) [1]. DD prevalence increases significantly with age, ranging from 10–20% in those younger than 40 years up to 50 to 70% in those older than 70–80 years [2, 3]. While diverticulitis occurs in around 5% (1.7% complicated) of patients with diverticulosis [4], admission rate is steadily increasing overall and at a higher rate in younger patients [5]. Along with the different clinical presentations and populations affected by DD, diagnosis and treatments have consistently changed. Population, natural history, presentation, severity, and treatment for DD are heterogeneous, and optimal care for patients with DD needs highquality evidence from large cohort studies [15]. Very few prospective cohort studies explore the outcomes between the different presentations and treatments for DD

Objectives

Methods

Findings

Discussion

Conclusion