Registro Malattia Diverticolare (Registry of Diverticular Disease)

• Conditions: Diverticulum, Colon; Diverticulitis

• Registration Number: NCT03325829
• Lead Sponsor: Gruppo Italiano Malattia Diverticolare

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-06
• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-26
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-30
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1217

Inclusion Criteria

All consecutive patients satisfying the following inclusion criteria are recruited:

1. Acceptance to sign the Informed Consent form
2. Age >18
3. Instrumental evidence (endoscopic or radiological) of diverticula in the colon.

Exclusion Criteria

1. Refusal to sign the Informed Consent form
2. Inability to comply with the study procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk factors of diverticulosis/ diverticular disease	Five years	Evaluation of demographic and clinical characteristics, including comorbidities and co-treatment, able to characterize the subgroups of patients with diverticular disease

Secondary Outcome Measures

Name	Time	Method
Risk of complications of diverticular disease and the factors of risk and protection against complications	Five years	To evaluate risk factors for occurrence and recurrence of diverticulitis