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

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.

Conditions

• Colorectal Cancer

Interventions

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

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Jean Paul Galmiche, MD · Nantes University Hospital

• Stanislas Chaussade, MD · Hôpital Cochin

• Marie-Georges Lapalus, MD · Hospices Civils de Lyon

• Christophe Cellier, MD · CHU Pompidou

• Denis Heresbach, MD · Rennes University Hospital

• Bernard Filoche, MD · CH de Saint Philibert

• Vincent Maunoury, MD · CHU de Lille

• Gerard Gay, MD · Central Hospital, Nancy, France

• Thierry Barrioz, MD · Poitiers University Hospital

• Emmanuel Ben Soussan, MD · University Hospital, Rouen

• Dimitri Coumaros, MD · CHU de Strasbourg

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2009-07-31

Completion

2009-07-31

Countries

• France

Study Locations