Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Unknown status
CT.gov ID
NCT04279821
Collaborator
(none)
50
1
12.9
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD): an Observational Study
    Actual Study Start Date :
    Feb 1, 2020
    Anticipated Primary Completion Date :
    Feb 1, 2021
    Anticipated Study Completion Date :
    Mar 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Colonic diverticulosis and macroscopic signs of inflammation

    No interventional study

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with Segmental Colitis Associated With Colic Diverticulosis (SCAD) as assessed by histology [1 year]

      Number of patients with histological diagnosis of SCAD in patients with endoscopic signs of inflammation of the interdiverticular mucosa

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Sant'Andrea, University Sapienza Rome Rome Italy 00189

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bruno Annibale, Full Professor, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT04279821
    Other Study ID Numbers:
    • 263 SA_2019
    First Posted:
    Feb 21, 2020
    Last Update Posted:
    Feb 26, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bruno Annibale, Full Professor, University of Roma La Sapienza
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 26, 2020