Diverticulosis, Colonic Clinical Trial
Official title:
Prevalence of Segmental Colitis Associated With Colic Diverticulosis (SCAD): an Observational Study
NCT number | NCT04279821 |
Other study ID # | 263 SA_2019 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2020 |
Est. completion date | March 1, 2021 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital Sant'Andrea, University Sapienza Rome | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03602677 -
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
|
N/A | |
Completed |
NCT00535652 -
Concentration of Ertapenem in Colorectal Tissue
|
Phase 4 | |
Not yet recruiting |
NCT03465293 -
Influence of Mechanical Bowel Preparation on GI Microbiota
|
N/A | |
Completed |
NCT03619538 -
Interest of the Nefopam and PCA Morphine Combination for Postoperative Analgesia in Patients Undergoing Colon Surgery
|
N/A | |
Completed |
NCT05106101 -
L-glutamine Treatment in Patients With Diverticulosis
|
Phase 1 | |
Recruiting |
NCT02752360 -
Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis
|
Phase 1 | |
Completed |
NCT00663247 -
Mechanistic Randomized Controlled Trial (RCT) of Mesalazine in Symptomatic Diverticular Disease
|
N/A | |
Completed |
NCT05384925 -
Prior Abdominal Surgery: A Potential Risk Factor for Colonic Diverticulosis or Diverticulitis
|