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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: diet and absorption of ColoPEG; Procedure: Colonoscopy with colic videocapsule; Procedure: Standard colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Sacher-Huvelin S, Coron E, Gaudric M, Planche L, Benamouzig R, Maunoury V, Filoche B, Frederic 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 16, 2007
• First Submitted That Met QC Criteria: February 16, 2007
• First Posted (Estimate): February 19, 2007

Study Record Updates

• Last Update Posted (Estimate): July 23, 2009
• Last Update Submitted That Met QC Criteria: July 21, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: patients; polyps; asymptomatic; high risk; medium risk; cancers; between 50 and 74 years old; case; history of neoplastic colic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BRD 06/12-L