Back to results

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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

diet and absorption of ColoPEG

Colonoscopy with colic videocapsule

Standard colonoscopy

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring patients, medium risk, asymptomatic, between 50 and 74 years old, high risk, case, history of neoplastic colic, cancers, polyps

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Nantes

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00436514

First Posted

February 16, 2007

Last Updated

July 21, 2009

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00436514

Brief Title

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

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nantes University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

diet and absorption of ColoPEG

Intervention Description

4l of PEG during 2 days

Intervention Type

Procedure

Intervention Name(s)

Colonoscopy with colic videocapsule

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard colonoscopy

Intervention Description

1l of PEG the morning just before colonoscopy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials: