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Trial record 1 of 1 for:    NCT01557101
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Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population (CRIBADO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557101
First Posted: March 19, 2012
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital Universitario de Canarias
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer, Genetics of Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE Procedure: OPTICAL COLONOSCOPY ADHERENCE Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population

Resource links provided by NLM:


Further study details as provided by Hospital Universitario de Canarias:

Primary Outcome Measures:
  • Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer [ Time Frame: 6 month follow up ]
    Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer


Enrollment: 200
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
COLON CAPSULE ENDOSCOPY Procedure: 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.
OPTICAL COLONOSCOPY Procedure: OPTICAL COLONOSCOPY ADHERENCE
An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557101


Locations
Spain
Digestive Service, Huc
La Laguna, S/c de Tenerife, Spain, 38320
Hospital Universitario de Canarias
La Laguna, S/c de Tenerife, Spain, 38320
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: Enrique Quintero, MD. PhD. Hospital Universitario de Canarias
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01557101     History of Changes
Other Study ID Numbers: CEC_cribado_CCR
First Submitted: March 13, 2012
First Posted: March 19, 2012
Last Update Posted: January 9, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases