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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00436514
Enrollment
550
Registered
2007-02-19
Start date
2007-04-30
Completion date
2009-07-31
Last updated
2009-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

patients, medium risk, asymptomatic, between 50 and 74 years old, high risk, case, history of neoplastic colic, cancers, polyps

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.

Interventions

BEHAVIORALdiet and absorption of ColoPEG

4l of PEG during 2 days

PROCEDUREColonoscopy with colic videocapsule

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

PROCEDUREStandard colonoscopy

1l of PEG the morning just before colonoscopy

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026