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

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00436514
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Study Start: 2007-04
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-21
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France