Colonic Disease
Conditions
Brief summary
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.
Detailed description
Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy). Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria
Interventions
DEVICEPillcam Crohn's Capsule Endoscopy
Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy
Sponsors
Medtronic
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients who could avoid colonoscopy | 6 months | To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CE diagnostic yield and adenoma detection rate (ADR) | 6 months | Number of adenoma detected by CE |
| To compare CE and CC findings | 6 months | Compare findings between both techniques |
Countries
Spain
Contacts
Primary ContactBEGOÑA GONZALEZ SUAREZ, MD, PhD
Backup ContactMiguel Urpí Ferreruela, MD
Outcome results
None listed