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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370928
• Other study ID #: PCF-Y0014-L
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2011
• Last updated: April 26, 2012
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 54 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenomas
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• Olympus PCF-Y0014-L
Screening colonoscopy with a prototype colonoscope
• Standard colonoscope
Screening colonoscopy

Locations

Country	Name	City	State
Norway	Sørlandet Sykehus HF	Kristiansand

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No