Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

NCT04279821 | Unknown DMC

• 1 other identifier: 263 SA_2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticular Disease of Colon; Diverticulosis, Colonic

Keywords

Segmental colitis associated with colic diverticulosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Colonic diverticulosis and macroscopic signs of inflammation

No interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

University Hospital Sant'Andrea, University Sapienza Rome

Rome, 00189, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 16498252 BACKGROUND

• 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.

  PMID: 14987890 BACKGROUND

• 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.

  PMID: 25360320 BACKGROUND

• 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.

  PMID: 18338265 BACKGROUND

MeSH Terms

Conditions

Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Bruno Annibale, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Annibale, MD

CONTACT

0633775695; bruno.annibale@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 21, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)