Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)
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StatusRecruiting
Sponsors
University of Roma La Sapienza
CLINICAL TRIAL: NCT04279821
BioSeek: nct04279821
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 02/12/2020 |
| Estimated Enrollment Submitted: | 02/18/2020 |
| First Posted: | 02/20/2020 |
| Last Update Submitted: | 02/22/2020 |
| Last Update Posted: | 02/25/2020 |
| Actual Study Start Date: | 01/31/2020 |
| Estimated Primary Completion Date: | 01/31/2021 |
| Estimated Study Completion Date: | 02/28/2021 |
Condition or disease
Diverticular Disease of Colon
Diverticulosis, Colonic
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Colonic diverticulosis and macroscopic signs of inflammation No interventional study |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
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
