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

Colorectal Cancer, Genetics of Clinical Trial

— CRIBADO  

Official title:

Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557101
• Other study ID #: CEC_cribado_CCR
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2012
• Last updated: January 8, 2014
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer, Genetics of
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Digestive Service, Huc	La Laguna	S/c de Tenerife
Spain	Hospital Universitario de Canarias	La Laguna	S/c de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer	Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer	6 month follow up	Yes