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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436514
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : July 23, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: diet and absorption of ColoPEG Procedure: Colonoscopy with colic videocapsule Procedure: Standard colonoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
Study Start Date : April 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436514

CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Study Director: Jean Paul Galmiche, MD CHU de Nantes
Principal Investigator: Stanislas Chaussade, MD Hôpital Cochin
Principal Investigator: Marie-Georges Lapalus, MD CHU de Lyon
Principal Investigator: Christophe Cellier, MD CHU Pompidou
Principal Investigator: Denis Heresbach, MD Rennes University Hospital
Principal Investigator: Bernard Filoche, MD CH de Saint Philibert
Principal Investigator: Vincent Maunoury, MD CHU de Lille
Principal Investigator: Gerard Gay, MD CHU de Nancy
Principal Investigator: Thierry Barrioz, MD Poitiers University Hospital
Principal Investigator: Emmanuel Ben Soussan, MD CHU de Rouen
Principal Investigator: Dimitri Coumaros, MD CHU de Strasbourg

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pr Jean Paul Galmiche, CHU de Nantes Identifier: NCT00436514     History of Changes
Other Study ID Numbers: BRD 06/12-L
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009

Keywords provided by Nantes University Hospital:
medium risk
between 50 and 74 years old
high risk
history of neoplastic colic

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases