An observational study in Diverticulum, Colon and Diverticulitis, sponsored by Gruppo Italiano Malattia Diverticolare. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-30.
Sponsored by Gruppo Italiano Malattia Diverticolare · Observational
To determine the clinical characteristics and risk factors for the onset of diverticular disease and its complications in the Italian population.
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:
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 1,217 is above the median of 275 across 59 observational studies indexed under Diverticulitis.
Browse Diverticulitis studies →This is the only study on the registry with Gruppo Italiano Malattia Diverticolare as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients with colonic diverticula
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All consecutive patients satisfying the following inclusion criteria are recruited:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No interventional study
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
Time frame: Five years
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
Time frame: Five years
Clinical aspects of diverticulosis/ diverticular disease
To evaluate clinical characteristics associated to diverticulosis, symptomatic uncomplicated diverticular disease and diverticulitis
Time frame: Five years
No study locations are listed for this record.
Ran from Apr 2015 to primary completion in Jun 2015, 2 months.
Of 22 observational studies under Diverticulitis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 101. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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