Capsule Endoscopy as an Alternative to Colonoscopy

Study Overview
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Brief Summary
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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
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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

Official Title
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Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?

Conditions
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Colonic Disease

Intervention / Treatment
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* Device: Pillcam Crohn's Capsule Endoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pillcam Crohn's Capsule Endoscopy and colonoscopy<br>All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy | Device: Pillcam Crohn's Capsule Endoscopy<br>* Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy<br>* Other names: Pillcam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CE diagnostic yield and adenoma detection rate (ADR) | Number of adenoma detected by CE | 6 months | 
| To compare CE and CC findings | Compare findings between both techniques | 6 months |