Registro Malattia Diverticolare (Registry of Diverticular Disease)
Nyckelord
Abstrakt
Beskrivning
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
Datum
| Senast verifierad: | 09/30/2017 |
| Först skickat: | 10/25/2017 |
| Beräknad anmälan inlämnad: | 10/25/2017 |
| Först publicerad: | 10/29/2017 |
| Senaste uppdatering skickad: | 10/25/2017 |
| Senaste uppdatering publicerad: | 10/29/2017 |
| Faktiskt startdatum för studien: | 03/31/2015 |
| Uppskattat primärt slutdatum: | 05/31/2015 |
| Beräknat slutfört datum: | 03/31/2020 |
Tillstånd eller sjukdom
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| Patients with colonic diverticula No interventional study |
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Testmetod | Non-Probability Sample |
| Accepterar friska volontärer | Nej |
| Kriterier | 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 |
Resultat
Primära resultatåtgärder
1. Risk factors of diverticulosis/ diverticular disease [Five years]
Sekundära resultatåtgärder
1. Risk of complications of diverticular disease and the factors of risk and protection against complications [Five years]
Andra resultatåtgärder
1. Clinical aspects of diverticulosis/ diverticular disease [Five years]
