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

April 26, 2012 updated by: Sorlandet Hospital HF
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway, 4604
        • Sørlandet Sykehus HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

54 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prototype colonoscope
The new colonoscope to be tested
Device: Olympus PCF-Y0014-L
Screening colonoscopy with a prototype colonoscope
Other Names:
  • Olympus PCF-Y0014-L colonoscope
Active Comparator: Standard colonoscope
The standard colonoscope used world-wide today.
Device: Standard colonoscope
Screening colonoscopy
Other Names:
  • Olympus series 160 colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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.
1 hour
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.
10 minutes
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Investigators

  • Study Chair: Michael Bretthauer, MD, Ph.d., Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

June 9, 2011

First Posted (Estimate)

June 10, 2011

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCF-Y0014-L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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