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Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01370928
First received: March 21, 2011
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.


Condition Intervention Phase
Colorectal Cancer
Adenomas
 Device: Olympus PCF-Y0014-L
Device: Standard colonoscope
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Patients´ evaluation of pain and discomfort [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.


Secondary Outcome Measures:
  • Time used to reach the caecum [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    The time used to reach the caecum will be recorded with a stop watch during the procedure.

  • Need for sedation/analgesics during the colonoscopy procedure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.

  • Need to change to a different colonoscope to complete the procedure [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    If the colonoscopist decides to change to a different colonoscope during the procedure, the reason is recorded immediately after the procedure. The number of procedures where there is a change of colonoscope will be recorded.

  • Caecum intubation rate [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.


Enrollment: 190
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prototype colonoscope
The new colonoscope to be tested
 Device: Olympus PCF-Y0014-L
Screening colonoscopy with a prototype colonoscope
Other Name: Olympus PCF-Y0014-L colonoscope
Active Comparator: Standard colonoscope
The standard colonoscope used world-wide today.
 Device: Standard colonoscope
Screening colonoscopy
Other Name: Olympus series 160 colonoscope

  Eligibility

Ages Eligible for Study:   54 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons included in the NordICC trial are eligible for inclusion
  • For information about the NordICC trial see clinicaltrials.gov NCT00883792

Exclusion Criteria:

  • Pregnancy
  • Persons younger than 18 years
  • Persons unable to comprehend the information given
  • not possible to start the examination without prior administration of sedation/analgesics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370928

Locations
Norway
Sørlandet Sykehus HF
Kristiansand, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Chair: Michael Bretthauer, MD, Ph.d. Oslo University Hospital
  More Information

No publications provided by Sorlandet Hospital HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01370928     History of Changes
Other Study ID Numbers: PCF-Y0014-L
Study First Received: March 21, 2011
Last Updated: April 26, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Sorlandet Hospital HF:
Colonoscopy performance
Pain
Discomfort
 Screening
Colorectal cancer
Colorectal cancer screening, diagnostics of adenomas

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013