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Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

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ClinicalTrials.gov Identifier: NCT04279821
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Bruno Annibale, University of Roma La Sapienza

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
Diverticular Disease of Colon Diverticulosis, Colonic

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Study Type : Observational
Estimated 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 : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of patients with Segmental Colitis Associated With Colic Diverticulosis (SCAD) as assessed by histology [ Time Frame: 1 year ]
    Number of patients with histological diagnosis of SCAD in patients with endoscopic signs of inflammation of the interdiverticular mucosa



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279821


Contacts
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Contact: Bruno Annibale, MD 0633775695 ext +39 bruno.annibale@uniroma1.it

Locations
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Italy
University Hospital Sant'Andrea, University Sapienza Rome Recruiting
Rome, Italy, 00189
Contact: Bruno Annibale, MD    0633775695 ext +39    bruno.annibale@uniroma1.it   
Contact: Emilio Di Giulio, MD    0633776151 ext +39    emilio.digiulio@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Bruno Annibale, MD University of Roma La Sapienza
Publications:
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Responsible Party: Bruno Annibale, Full Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04279821    
Other Study ID Numbers: 263 SA_2019
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruno Annibale, University of Roma La Sapienza:
Segmental colitis associated with colic diverticulosis
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Colitis
Diverticulosis, Colonic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Intraabdominal Infections
Infection
Pathological Conditions, Anatomical