Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.

Study Overview
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Brief Summary
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Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Haemoccult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitute an invasive method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasive method is required.

Official Title
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Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: diet and absorption of ColoPEG
* Procedure: Colonoscopy with colic videocapsule
* Procedure: Standard colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years patient able to give his informed consent No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies No signs of stenosis of small intestine or colon No contraindication to anesthesia No participation to an other clinical study Patient with and indication to colonoscopy for searching of a colorectal neoplasia during a screening program OR Patient for who a endoscopic following is required because of familial cases or personal cases of polyps or colorectal cancer Exclusion Criteria: Presence of symptoms evocating an occlusive pathology Recent complicated colic diverticulosis No informed consent pregnancy or no use of efficient contraception treatment Patient with a pace-maker or others internal medical electronic device Evolved nephric or cardiac insufficiencies Hypersensibility to Fleet Phospho Soda (or one of the excipient), bisacodyl (or one of the excipient), motilium (or one of the excipient) Presence of a prolactinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet and absorption of ColoPEG|4l of PEG during 2 days|
|Procedure: Colonoscopy with colic videocapsule|2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative)|
|Procedure: Standard colonoscopy|1l of PEG the morning just before colonoscopy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancers, patients, medium risk, asymptomatic, between 50 and 74 years old, high risk, case, history of neoplastic colic, polyps