Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03325829
Study type Observational [Patient Registry]
Source Gruppo Italiano Malattia Diverticolare
Contact
Status Active, not recruiting
Phase N/A
Start date April 2015
Completion date April 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01081054 - Hospitalization or Ambulatory Treatment of Acute Diverticulitis Phase 4
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT03337984 - Damage Control Surgery in the Treatment of Complicated Diverticulitis
Recruiting NCT06210724 - FIT in Diverticulitis
Completed NCT01986686 - Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis N/A
Completed NCT01477190 - Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program Phase 1/Phase 2
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Completed NCT00468455 - Post-Op Quality of Life After Colorectal Surgery N/A
Enrolling by invitation NCT03700593 - Feasibility and Safety of Single Port Robot in Colorectal Procedures
Recruiting NCT04095663 - Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial N/A
Completed NCT00545740 - Prevention of Recurrence of Diverticulitis Phase 3
Recruiting NCT01837342 - Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery N/A
Completed NCT01727388 - Informativeness to Digital Rectal Examination Phase 3
Completed NCT00554099 - Asacol Acute Diverticulitis(DIVA)Study Phase 2
Completed NCT04173182 - Confocal Laser Endomicrospy in Colonic Diverticular Disease
Completed NCT01560377 - Perfusion Assessment in Laparoscopic Left Anterior Resection Phase 1