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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370928
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
Sorlandet Hospital HF

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Cancer Adenomas Device: Olympus PCF-Y0014-L Device: Standard colonoscope Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Study Start Date : March 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Patients´ evaluation of pain and discomfort [ Time Frame: 24 hours ]
    Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.

Secondary Outcome Measures :
  1. Time used to reach the caecum [ Time Frame: 1 hour ]
    The time used to reach the caecum will be recorded with a stop watch during the procedure.

  2. Need for sedation/analgesics during the colonoscopy procedure [ Time Frame: 1 hour ]
    If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.

  3. Need to change to a different colonoscope to complete the procedure [ Time Frame: 10 minutes ]
    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.

  4. Caecum intubation rate [ Time Frame: 30 minutes ]
    The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   54 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Persons included in the NordICC trial are eligible for inclusion
  • For information about the NordICC trial see 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01370928

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Sørlandet Sykehus HF
Kristiansand, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
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Study Chair: Michael Bretthauer, MD, Ph.d. Oslo University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sorlandet Hospital HF Identifier: NCT01370928    
Other Study ID Numbers: PCF-Y0014-L
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Sorlandet Hospital HF:
Colonoscopy performance
Colorectal cancer
Colorectal cancer screening, diagnostics of adenomas
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type