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

Phase 4

Completed

• Conditions: Colorectal Cancer, Genetics of
• Interventions: Procedure: OPTICAL COLONOSCOPY ADHERENCE; Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE

• Registration Number: NCT01557101
• Lead Sponsor: Hospital Universitario de Canarias

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.

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 Timeline

• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTICAL COLONOSCOPY	OPTICAL COLONOSCOPY ADHERENCE	-
COLON CAPSULE ENDOSCOPY	COLON CAPSULE ENDOSCOPY ADHERENCE	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Digestive Service, Huc; 🇪🇸 La Laguna, S/c de Tenerife, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, S/c de Tenerife, Spain