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

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00436514
First received: February 16, 2007
Last updated: July 21, 2009
Last verified: July 2009

February 16, 2007
July 21, 2009
April 2007
July 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00436514 on ClinicalTrials.gov Archive Site
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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.
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 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.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Colorectal Cancer
  • 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
Not Provided
Sacher-Huvelin S, Coron E, Gaudric M, Planche L, Benamouzig R, Maunoury V, Filoche B, Frédéric M, Saurin JC, Subtil C, Lecleire S, Cellier C, Coumaros D, Heresbach D, Galmiche JP. Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer. Aliment Pharmacol Ther. 2010 Nov;32(9):1145-53. doi: 10.1111/j.1365-2036.2010.04458.x. Epub 2010 Sep 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00436514
BRD 06/12-L
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Pr Jean Paul Galmiche, CHU de Nantes
Nantes University Hospital
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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 CHU de Rennes
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
Nantes University Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP