Clinical Trial: Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population

Brief Summary: The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nice

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 days ]

The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.


Original Primary Outcome: Diagnostic of at least one adenomatous lesion or cancer with both interventions(capsule endoscopy and colonoscopy) to compare them [ Time Frame: at 1 week ]

The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.


Current Secondary Outcome: Pain Scores on the Visual Analog Scale [ Time Frame: 7 days ]

Presence of at least one polyp at capsule endoscopy and colonoscopy with both operators unaware of each other's findings until completion of the procedures.

Comparison of the different class of size for all polyps Comparison of Kudo and Paris classification of the polyps at endoscopy capsule and colonoscopy Tolerance, pain and discomfort between the both procedure Acceptability of both procedure at day 1 and day 7 Accuracy of the localization of the polyp or the lesion at the capsule endosocpy comparated with the colonoscopy topography (Gold standard).



Original Secondary Outcome: Comparaison of lesion determined specification between both interventions [ Time Frame: at 1 week ]

Presence of at least one polyp at capsule endoscopy and colonoscopy with both operators unaware of each other's findings until completion of the procedures.

Comparison of the different class of size for all polyps Comparison of Kudo and Paris classification of the polyps at endoscopy capsule and colonoscopy Tolerance, pain and discomfort between the both procedure Acceptability of both procedure at day 1 and day 7 Accuracy of the localization of the polyp or the lesion at the capsule endosocpy comparated with the colonoscopy topography (Gold standard).



Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: July 26, 2010
Date Started: August 2010
Date Completion: November 2013
Last Updated: April 23, 2013
Last Verified: May 2010