Registro Malattia Diverticolare (Registry of Diverticular Disease)

Diverticulitis Clinical Trial

— REMAD  

Official title:

Diverticular Disease Register (REMAD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03325829
• Other study ID #: REMAD Registry
• Status: Active, not recruiting
• Phase: N/A
• First received: October 26, 2017
• Last updated: October 26, 2017
• Start date: April 2015
• Est. completion date: April 2020

Study information

• Verified date: October 2017
• Source: Gruppo Italiano Malattia Diverticolare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1217
• Est. completion date: April 2020
• Est. primary completion date: June 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulum
• Diverticulum, Colon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattia Diverticolare

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical aspects of diverticulosis/ diverticular disease	To evaluate clinical characteristics associated to diverticulosis, symptomatic uncomplicated diverticular disease and diverticulitis	Five years
Primary	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	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