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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436514
• Other study ID #: BRD 06/12-L
• Status: Completed
• Phase: N/A
• First received: February 16, 2007
• Last updated: July 21, 2009
• Start date: April 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• diet and absorption of ColoPEG
4l of PEG during 2 days

Procedure:
• Colonoscopy with colic videocapsule
2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative)
• Standard colonoscopy
1l of PEG the morning just before colonoscopy

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,