Clinical trial NCT00436514: Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
Official title: Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: patients
medium risk
asymptomatic
between 50 and 74 years old
high risk
case
history of neoplastic colic
cancers
polyps
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2007-02-19
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Jean Paul Galmiche, MD
role: STUDY_DIRECTOR
affiliation: Hôpital Cochin
name: Stanislas Chaussade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Marie-Georges Lapalus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Pompidou
name: Christophe Cellier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Denis Heresbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Saint Philibert
name: Bernard Filoche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Lille
name: Vincent Maunoury, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Gerard Gay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poitiers University Hospital
name: Thierry Barrioz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Emmanuel Ben Soussan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Strasbourg
name: Dimitri Coumaros, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.