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Status unknownNCT04279821Updated Feb 26, 2020

Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

An observational study in Diverticular Disease of Colon and Diverticulosis, Colonic, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by University of Roma La Sapienza · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Diverticular Disease of Colon
  • Diverticulosis, Colonic

Keywords

  • Segmental colitis associated with colic diverticulosis
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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's planned enrollment of 50 is below the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Colonic diverticulosis and macroscopic signs of inflammation

    No interventional study

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What researchers measure

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 16498252 ↗
  • 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. PubMed 14987890 ↗
  • 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. PubMed 25360320 ↗
  • 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. PubMed 18338265 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04279821
Lead sponsor
University of Roma La Sapienza
Responsible party
Bruno Annibale (Full Professor, University of Roma La Sapienza) — Principal investigator
First posted
Feb 21, 2020
Start date
Feb 1, 2020
Primary completion
Feb 1, 2021 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Feb 26, 2020

Study contacts

Bruno Annibale, MD
Contact
bruno.annibale@uniroma1.it
0633775695 ext. +39
Bruno Annibale, MD
principal investigator · University of Roma La Sapienza

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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