Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD): an Observational Study

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.

Study Overview

• Status: Unknown
• Conditions: Diverticulosis, Colonic; Diverticular Disease of Colon

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00189
    • Recruiting
    • University Hospital Sant'Andrea, University Sapienza Rome
    • Contact: Bruno Annibale, MD; Phone Number: +39 0633775695; Email: bruno.annibale@uniroma1.it
    • Contact: Emilio Di Giulio, MD; Phone Number: +39 0633776151; Email: emilio.digiulio@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Colonic diverticulosis and macroscopic signs of inflammation; No interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Bruno Annibale, MD, University of Roma La Sapienza

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Segmental colitis associated with colic diverticulosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Colitis; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic
• Other Study ID Numbers: 263 SA_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No