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

• Sponsor: Hospital Universitario de Canarias (Other)
• Overall Status: Completed
• CT.gov ID: NCT01557101
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 100
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer, Genetics of	Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE; Procedure: OPTICAL COLONOSCOPY ADHERENCE	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• 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
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: OPTICAL COLONOSCOPY	Procedure: OPTICAL COLONOSCOPY ADHERENCE; An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.

Outcome Measures

Primary Outcome Measures

1. Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer [6 month follow up]

   Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Digestive Service, Huc	La Laguna	S/c de Tenerife	Spain	38320
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitario de Canarias
• ClinicalTrials.gov Identifier: NCT01557101
• Other Study ID Numbers: CEC_cribado_CCR
• First Posted: Mar 19, 2012
• Last Update Posted: Jan 9, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Jan 9, 2014