Registro Malattia Diverticolare (Registry of Diverticular Disease) (REMAD)

Diverticular Disease Register (REMAD)

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

Study Overview

• Status: Unknown
• Conditions: Diverticulitis; Diverticulum, Colon

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 Type: Observational
• Enrollment (Actual): 1217

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with colonic diverticula

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with colonic diverticula; No interventional study

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of complications of diverticular disease and the factors of risk and protection against complications	To evaluate risk factors for occurrence and recurrence of diverticulitis	Five years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical aspects of diverticulosis/ diverticular disease	To evaluate clinical characteristics associated to diverticulosis, symptomatic uncomplicated diverticular disease and diverticulitis	Five years

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattia Diverticolare

Publications and helpful links

General Publications

• Annibale B, Lahner E, Maconi G, Usai P, Marchi S, Bassotti G, Barbara G, Cuomo R. Clinical features of symptomatic uncomplicated diverticular disease: a multicenter Italian survey. Int J Colorectal Dis. 2012 Sep;27(9):1151-9. doi: 10.1007/s00384-012-1488-5. Epub 2012 May 10.
• Cuomo R, Barbara G, Andreozzi P, Bassotti G, Casetti T, Grassini M, Ierardi E, Maconi G, Marchi S, Sarnelli G, Savarino V, Usai P, Vozzella L, Annibale B. Symptom patterns can distinguish diverticular disease from irritable bowel syndrome. Eur J Clin Invest. 2013 Nov;43(11):1147-55. doi: 10.1111/eci.12152. Epub 2013 Sep 2.
• Annibale B, Maconi G, Lahner E, De Giorgi F, Cuomo R. Efficacy of Lactobacillus paracasei sub. paracasei F19 on abdominal symptoms in patients with symptomatic uncomplicated diverticular disease: a pilot study. Minerva Gastroenterol Dietol. 2011 Mar;57(1):13-22.
• Maconi G, Barbara G, Bosetti C, Cuomo R, Annibale B. Treatment of diverticular disease of the colon and prevention of acute diverticulitis: a systematic review. Dis Colon Rectum. 2011 Oct;54(10):1326-38. doi: 10.1097/DCR.0b013e318223cb2b.
• Zullo A, Hassan C, Maconi G, Manes G, Tammaro G, De Francesco V, Annibale B, Ficano L, Buri L, Gatto G, Lorenzetti R, Campo SM, Ierardi E, Pace F, Morini S. Cyclic antibiotic therapy for diverticular disease: a critical reappraisal. J Gastrointestin Liver Dis. 2010 Sep;19(3):295-302.
• Cremon C, Carabotti M, Cuomo R, Pace F, Andreozzi P, Barbaro MR, Annibale B, Barbara G. Italian nationwide survey of pharmacologic treatments in diverticular disease: Results from the REMAD registry. United European Gastroenterol J. 2019 Jul;7(6):815-824. doi: 10.1177/2050640619845990. Epub 2019 Apr 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Registry; Diverticulitis; Uncomplicated Diverticular Disease; Diverticular Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulitis; Diverticulum; Diverticular Diseases; Diverticulum, Colon
• Other Study ID Numbers: REMAD Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No