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

Phase 3

Completed

• Conditions: Colorectal Cancer; Adenomas
• Interventions: Device: Olympus PCF-Y0014-L; Device: Standard colonoscope

• Registration Number: NCT01370928
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-21
• Primary Completion: 2011-06
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prototype colonoscope	Olympus PCF-Y0014-L	The new colonoscope to be tested
Standard colonoscope	Standard colonoscope	The standard colonoscope used world-wide today.

Primary Outcome Measures

Name	Time	Method
Patients´ evaluation of pain and discomfort	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

Name	Time	Method
Time used to reach the caecum	1 hour	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	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.
Need to change to a different colonoscope to complete the procedure	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.
Caecum intubation rate	30 minutes	The colonic segment reached during each colonoscopy is recorded immediately following the procedure. Caecal intubation rate describes the number of complete colonoscopies.

Trial Locations

Locations (1)

Sørlandet Sykehus HF; 🇳🇴 Kristiansand, Norway