Colonic Disease Clinical Trial
— CAPSUCOVIDOfficial title:
Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.
Status | Recruiting |
Enrollment | 704 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years - Rectal bleeding/haematochezia in patients >50 years who have undergone a colonoscopy <5 years ago or <50 years with no risk factors for CRC - Chronic constipation/abdominal distension/abdominal pain/diarrhea - Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed - Recent change in bowel habits - Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease Exclusion Criteria: - Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis - Evaluation following fragmented resection (recurrence ruled out) - Patients with a positive FIT - Pregnancy or breast-feeding - Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices. - Allergy or known contraindication to the medications and preparations agents used in the procedure. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital clinic of barcelona | Barcelona | |
Spain | Hospital Sant Pau | Barcelona | |
Spain | Hospital universitario de Santa Cruz de Tenerife | Santa Cruz De Tenerife | Canarias |
Spain | Hospital Mutua de Terrassa | Terrassa |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Medtronic |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of patients who could avoid colonoscopy | To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE | 6 months | |
Secondary | CE diagnostic yield and adenoma detection rate (ADR) | Number of adenoma detected by CE | 6 months | |
Secondary | To compare CE and CC findings | Compare findings between both techniques | 6 months |
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