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


Phase 4
40 Years
65 Years
Open (Enrolling)
Both
Colorectal Cancer, Genetics of

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer

Outcome Description:

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

Outcome Time Frame:

6 month follow up

Safety Issue:

Yes

Principal Investigator

Enrique Quintero, MD. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario de Canarias

Authority:

Spain: Ethics Committee

Study ID:

CEC_cribado_CCR

NCT ID:

NCT01557101

Start Date:

April 2012

Completion Date:

June 2013

Related Keywords:

  • Colorectal Cancer, Genetics of
  • Colorectal Neoplasms

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