Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.

NCT ID: NCT00436514

Last Updated: 2009-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-07-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

diet and absorption of ColoPEG

4l of PEG during 2 days

Intervention Type: BEHAVIORAL

Colonoscopy with colic videocapsule

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

Intervention Type: PROCEDURE

Standard colonoscopy

1l of PEG the morning just before colonoscopy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

CHU de Nantes

Principal Investigators

Jean Paul Galmiche, MD

Role: STUDY_DIRECTOR

Nantes University Hospital

Stanislas Chaussade, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cochin

Marie-Georges Lapalus, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Christophe Cellier, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Pompidou

Denis Heresbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Bernard Filoche, MD

Role: PRINCIPAL_INVESTIGATOR

CH de Saint Philibert

Vincent Maunoury, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Gerard Gay, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Thierry Barrioz, MD

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Emmanuel Ben Soussan, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Dimitri Coumaros, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Strasbourg

Locations

CHU de Nantes

Nantes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 21039676 (View on PubMed)

Other Identifiers

BRD 06/12-L

Identifier Type: -

Identifier Source: org_study_id