Back to resultsColonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Primary Purpose
Colorectal Cancer, Adenomas
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Olympus PCF-Y0014-L
Standard colonoscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colonoscopy performance, Pain, Discomfort, Screening, Colorectal cancer, Colorectal cancer screening, diagnostics of adenomas
Eligibility 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
Sites / Locations
- Sørlandet Sykehus HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prototype colonoscope
Standard colonoscope
Arm Description
The new colonoscope to be tested
The standard colonoscope used world-wide today.
Outcomes
Primary Outcome Measures
Patients´ evaluation of pain and discomfort
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
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
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
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
The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01370928
Brief Title
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Official Title
Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adenomas
Keywords
Colonoscopy performance, Pain, Discomfort, Screening, Colorectal cancer, Colorectal cancer screening, diagnostics of adenomas
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prototype colonoscope
Arm Type
Experimental
Arm Description
The new colonoscope to be tested
Arm Title
Standard colonoscope
Arm Type
Active Comparator
Arm Description
The standard colonoscope used world-wide today.
Intervention Type
Device
Intervention Name(s)
Olympus PCF-Y0014-L
Other Intervention Name(s)
Olympus PCF-Y0014-L colonoscope
Intervention Description
Screening colonoscopy with a prototype colonoscope
Intervention Type
Device
Intervention Name(s)
Standard colonoscope
Other Intervention Name(s)
Olympus series 160 colonoscope
Intervention Description
Screening colonoscopy
Primary Outcome Measure Information:
Title
Patients´ evaluation of pain and discomfort
Description
Analysis of validated feed-back questionnaires to be filled in on the day after the proceudre by the trial participants.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time used to reach the caecum
Description
The time used to reach the caecum will be recorded with a stop watch during the procedure.
Time Frame
1 hour
Title
Need for sedation/analgesics during the colonoscopy procedure
Description
If sedation/analgesics is administered during the colonoscopy procedure, the name of the agent, dose and route of administration will be recorded immediately.
Time Frame
1 hour
Title
Need to change to a different colonoscope to complete the procedure
Description
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.
Time Frame
10 minutes
Title
Caecum intubation rate
Description
The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
54 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bretthauer, MD, Ph.d.
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sørlandet Sykehus HF
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22622786
Citation
Garborg KK, Loberg M, Matre J, Holme O, Kalager M, Hoff G, Bretthauer M. Reduced pain during screening colonoscopy with an ultrathin colonoscope: a randomized controlled trial. Endoscopy. 2012 Aug;44(8):740-6. doi: 10.1055/s-0032-1309755. Epub 2012 May 23.
Results Reference
derived
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Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial
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