Clinical trial NCT04279821: Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)
Official title: Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD): an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diverticular Disease of Colon
Diverticulosis, Colonic
Keywords: Segmental colitis associated with colic diverticulosis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive adult patients (\>18 years of age) who perform a colonoscopy (for screening or other clinical/diagnostic reasons) during which diverticulosis of the colon is associated with macroscopic signs of inflammation (erythema, friability and ulcerations) of the interdiverticular mucosa, in a tertiary university centre.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with Segmental Colitis Associated With Colic Diverticulosis (SCAD) as assessed by histology
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Hospital Sant'Andrea, University Sapienza Rome
Study officials:
affiliation: University of Roma La Sapienza
name: Bruno Annibale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parra-Blanco A. Colonic diverticular disease: pathophysiology and clinical picture. Digestion. 2006;73 Suppl 1:47-57. doi: 10.1159/000089779. Epub 2006 Feb 8.
citation: Stollman N, Raskin JB. Diverticular disease of the colon. Lancet. 2004 Feb 21;363(9409):631-9. doi: 10.1016/S0140-6736(04)15597-9.
citation: 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.
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.