Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD)

Diverticulosis, Colonic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279821
• Other study ID #: 263 SA_2019
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2020
• Source: University of Roma La Sapienza
• Contact: Bruno Annibale, MD
• Phone: 0633775695
• Email: bruno.annibale[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Diverticular Disease of Colon
• Diverticulosis, Colonic
• Diverticulum

Locations

Country	Name	City	State
Italy	University Hospital Sant'Andrea, University Sapienza Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

Parra-Blanco A. Colonic diverticular disease: pathophysiology and clinical picture. Digestion. 2006;73 Suppl 1:47-57. Epub 2006 Feb 8. Review. — View Citation

Stollman N, Raskin JB. Diverticular disease of the colon. Lancet. 2004 Feb 21;363(9409):631-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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