Registro Malattia Diverticolare (Registry of Diverticular Disease) — REMAD  

Diverticulitis Clinical Trial

Official title: Diverticular Disease Register (REMAD)

Status Active, not recruiting

Clinical Trial Summary

To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population.

Clinical Trial Description

Diverticulosis and diverticular disease present a high prevalence rate in the world population, especially in the Western world. Diverticulosis of the colon is an extremely common condition in industrialized countries and its prevalence rate increases with age, and exceeds 60% in patients aged over eighty. Although the course of diverticulosis is normally free of symptoms and complications, about 15% of patients develop symptoms often undistinguishable from those of the irritable bowel syndrome, such as abdominal pain, bowel disorders and bloating. About 5% of patients with diverticular disease develop an episode of uncomplicated acute diverticulitis with abdominal symptoms accompanied in some cases by systemic symptoms, such as fever or malaise and laboratory evidence of activation of the inflammatory process. In a minority of these cases, the patient suffers major complications such as the development of abscesses, fistulae, haemorrhage or stenosis (1).

The pathogenesis of diverticulosis and diverticular disease remains unclear. Genetic predisposition, risk factors (2), relationships with the irritable bowel syndrome (3-5), a low-fibre diet, involvement of intestinal microbiota and the mucosal immune activation (6-7) remain elements whose significance is yet to be confirmed. The management, medical and surgical approach and the prevention of relapses of diverticular disease remain above all empirical and supported by few controlled clinical studies (8-9). This scenario of uncertainty may result in waste and diagnostic/therapeutic pathways not always suitable for a disease with such a high prevalence rate. On the basis of these considerations, there is a need to collect systematic information useful for determining aetiopathogenetic aspects and outcomes with greater accuracy.

OBJECTIVES OF THE STUDY

The purpose of the study is to structure a national register on an IT platform useful for determining:

1. The clinical aspects of diverticulosis/ diverticular disease

2. The risk factors of diverticulosis/ diverticular disease

3. The risk of complications of diverticular disease and the factors of risk and protection against complications.

4. The management of medical and surgical treatments ;

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulum
• Diverticulum, Colon

• NCT number: NCT03325829
• Study type: Observational [Patient Registry]
• Source: Gruppo Italiano Malattia Diverticolare
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Completion date: April 2020