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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04279821
Other study ID # 263 SA_2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date March 1, 2021

Study information

Verified date February 2020
Source University of Roma La Sapienza
Contact Bruno Annibale, MD
Phone 0633775695
Email bruno.annibale@uniroma1.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Colonic diverticula are common in Western countries, affecting up to 60% of subjects over 70 years of age. In about 80% of patients, colonic diverticula remain asymptomatic (diverticulosis), while approximately 20% of patients may develop abdominal symptoms (symptomatic uncomplicated diverticular disease, SUDD) and, eventually, complications such as bouts of diverticulitis or bleeding.

A small proportion of patients with colonic diverticulosis may develop segmental colitis associated with diverticulosis (SCAD). SCAD is separate clinical disease with specific macroscopic (erythema, friability and ulcerations) and microscopic features characterized by chronic, mucosal inflammation involving the inter-diverticular mucosa (usually sigmoid colon) sparing the proximal colon and rectum colon.

The most common symptoms of SCAD are rectal bleeding, diarrhoea and abdominal pain.

To achieve SCAD diagnosis a correct biopsies sampling is mandatory. It is necessary to take biopsies on the borders of the diverticula and in the apparently normal adjacent mucosa as well as biopsies in both the colon proximal to the diverticular area and the rectum in order to exclude chronic inflammatory bowel disease. The spectrum of histological lesions associated with SCAD is variable, including mild non-specific inflammation and inflammatory bowel disease (IBD)-like changes.

Currently, data regarding prevalence of SCAD are scarce. It has been estimated that in patients with diverticulosis, SCAD prevalence ranged from 0.3-1.3%.

The aim of the present study is to assess prospectively the prevalence of segmental colitis associated with colon diverticulosis (SCAD), in consecutive patients with colic diverticulosis, in a tertiary university centre.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Endoscopic finding of colonic diverticulosis associated with macroscopic signs of inflammation (erythema, friability and ulcerations) of the interdiverticular mucosa

Exclusion Criteria:

- inability to sign informed consent;

- impossibility to perform biopsies during colonoscopy (e.g. anticoagulant therapy/ conditions predisposing to high risk of bleeding);

- Diagnosis of chronic inflammatory bowel disease.

Study Design


Locations

Country Name City State
Italy University Hospital Sant'Andrea, University Sapienza Rome Rome

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068. — View Citation

Freeman HJ. Natural history and long-term clinical behavior of segmental colitis associated with diverticulosis (SCAD syndrome). Dig Dis Sci. 2008 Sep;53(9):2452-7. doi: 10.1007/s10620-007-0173-y. Epub 2008 Mar 13. — View Citation

Parra-Blanco A. Colonic diverticular disease: pathophysiology and clinical picture. Digestion. 2006;73 Suppl 1:47-57. Epub 2006 Feb 8. Review. — View Citation

Stollman N, Raskin JB. Diverticular disease of the colon. Lancet. 2004 Feb 21;363(9409):631-9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with Segmental Colitis Associated With Colic Diverticulosis (SCAD) as assessed by histology Number of patients with histological diagnosis of SCAD in patients with endoscopic signs of inflammation of the interdiverticular mucosa 1 year
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