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
  Purpose

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 Intervention
Colorectal Cancer
Behavioral: diet and absorption of ColoPEG
Procedure: Colonoscopy with colic videocapsule
Procedure: Standard colonoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Enrollment: 550
Study Start Date: April 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00436514

Locations
France
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Jean Paul Galmiche, CHU de Nantes
ClinicalTrials.gov Identifier: NCT00436514     History of Changes
Other Study ID Numbers: BRD 06/12-L
Study First Received: February 16, 2007
Last Updated: July 21, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on September 18, 2014