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临床试验/NCT03325829
NCT03325829Unknown不适用

Diverticular Disease Register (REMAD)

Gruppo Italiano Malattia Diverticolare0 个研究点目标入组 1,217 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,217
主要终点
Risk factors of diverticulosis/ diverticular disease

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All consecutive patients satisfying the following inclusion criteria are recruited:
  • Acceptance to sign the Informed Consent form
  • Instrumental evidence (endoscopic or radiological) of diverticula in the colon.

排除标准

  • Refusal to sign the Informed Consent form
  • Inability to comply with the study procedures

结局指标

主要结局

Risk factors of diverticulosis/ diverticular disease

时间窗: Five years

Evaluation of demographic and clinical characteristics, including comorbidities and co-treatment, able to characterize the subgroups of patients with diverticular disease

次要结局

  • Risk of complications of diverticular disease and the factors of risk and protection against complications(Five years)

研究者

发起方
Gruppo Italiano Malattia Diverticolare
申办方类型
Other
责任方
Principal Investigator
主要研究者

ROSARIO CUOMO

Associate Professor of Gastroenterology

Gruppo Italiano Malattia Diverticolare

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