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

Colorectal cancer is one of the most frequent and it pronosis is still serious. In France, diagnosis and screening applicated in numerous deprtements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Hemocult) 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 Hemocult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitu an invasiv method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasiv method is required.

Study Type: Interventional

Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment

Intervention(s) in this Clinical Trial

• 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

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 particpation 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 personnal cases of polypes or colorectal cancer

Exclusion Criteria:

• Presence of symptoms evocating an occlusiv pathology
• Recent complicated colic diverticulosis
• No infomed consent
• pregnancy or no use of efficient contraception treatment
• Patient with a pace-maker or others internal medical electronic device
• Evoluted nephric or cardic insufficiences
• 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 prolactinome

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nantes University Hospital

Overall Clinical Trial Officials and Contacts

Jean Paul Galmiche, MD Study Director CHU de Nantes  

Overall Contact: Jean Paul Galmiche, MD 0240083028 jeanpaul.galmiche@chu-nantes.fr

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00436514

Study ID Number: BRD 06/12-L

ClinicalTrials.gov Identifier: NCT00436514

Health Authority: France: Afssaps - French Health Products Safety Agency