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Registro Malattia Diverticolare (Registry of Diverticular Disease)

NCT ID: NCT03325829

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Diverticulum, Colon Diverticulitis

Keywords

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Registry Diverticular Disease Diverticulitis Uncomplicated Diverticular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with colonic diverticula

No interventional study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattia Diverticolare

OTHER

Sponsor Role lead

Responsible Party

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ROSARIO CUOMO

Associate Professor of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 22573184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23992370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21372765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21904150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20922195 (View on PubMed)

Carabotti M, Marasco G, Sbarigia C, Cuomo R, Barbara G, Pace F, Sarnelli G, Annibale B; at behalf of REMAD group. Site and duration of abdominal pain discriminate symptomatic uncomplicated diverticular disease from previous diverticulitis patients. Intern Emerg Med. 2024 Aug;19(5):1235-1245. doi: 10.1007/s11739-024-03588-6. Epub 2024 Apr 27.

Reference Type DERIVED
PMID: 38671294 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31316786 (View on PubMed)

Other Identifiers

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REMAD Registry

Identifier Type: -

Identifier Source: org_study_id