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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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diet and absorption of ColoPEG

Behavioral

4l of PEG during 2 days

Colonoscopy with colic videocapsule

Procedure

2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative)

Standard colonoscopy

Procedure

1l of PEG the morning just before colonoscopy

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Feb 19, 2007
Registry last updated: Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed