Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.

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Detailed Description

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The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.

Conditions

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Colorectal Cancer, Genetics of

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COLON CAPSULE ENDOSCOPY

Group Type OTHER

COLON CAPSULE ENDOSCOPY ADHERENCE

Intervention Type PROCEDURE

An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.

OPTICAL COLONOSCOPY

Group Type OTHER

OPTICAL COLONOSCOPY ADHERENCE

Intervention Type PROCEDURE

An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.

Interventions

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COLON CAPSULE ENDOSCOPY ADHERENCE

An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.

Intervention Type PROCEDURE

OPTICAL COLONOSCOPY ADHERENCE

An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age.
* Signing of informed consent.

Exclusion Criteria

* Personal history of adenoma or CRC.
* History of hereditary CRC.
* Chronic inflammatory disease.
* Presence of digestive symptoms.
* Patients with swallowing problems (dysphagia).
* Personal history of gastrointestinal surgery.
* Enteritis radioactive.
* Renal failure.
* Congestive heart failure
* Allergy or other contraindication to Bysacodyl to PEG or phosphates.
* Pregnancy.
* Suspected bowel obstruction or intestinal strictures or fistulas known.
* Colectomy.
* Paralysis with impaired intestinal motility.
* Any other process that the investigator's discretion to make inadequate participation.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes