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

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: Colorectal Cancer; Adenomas
• Intervention / Treatment: Device: Olympus PCF-Y0014-L; Device: Standard colonoscope

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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

• Sponsor: Sorlandet Hospital HF
• Investigators: Study Chair: Michael Bretthauer, MD, Ph.d., Oslo University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

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: Pain; Colorectal cancer; Screening; Discomfort; Colonoscopy performance; Colorectal cancer screening, diagnostics of adenomas
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: PCF-Y0014-L