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

NCT00436514 | Completed

• 1 other identifier: BRD 06/12-L
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Keywords

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

Interventions

diet and absorption of ColoPEG BEHAVIORAL

4l of PEG during 2 days

Colonoscopy with colic videocapsule PROCEDURE

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

Standard colonoscopy PROCEDURE

1l of PEG the morning just before colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Related Publications (1)

• 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.

  PMID: 21039676 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Polyps

Interventions

Diet; Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jean Paul Galmiche, MD

  Nantes University Hospital

  STUDY DIRECTOR

• Stanislas Chaussade, MD

  Hôpital Cochin

  PRINCIPAL INVESTIGATOR

• Marie-Georges Lapalus, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Christophe Cellier, MD

  CHU Pompidou

  PRINCIPAL INVESTIGATOR

• Denis Heresbach, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• Bernard Filoche, MD

  CH de Saint Philibert

  PRINCIPAL INVESTIGATOR

• Vincent Maunoury, MD

  CHU de Lille

  PRINCIPAL INVESTIGATOR

• Gerard Gay, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

• Thierry Barrioz, MD

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

• Emmanuel Ben Soussan, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

• Dimitri Coumaros, MD

  CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 23, 2009

Record last verified: 2009-07

Locations

FR (1)