Colonoscope Passive Bending Function

Not Applicable

Completed

• Conditions: Functional Colonic Disease; Colitis; Adenoma; Carcinoma
• Interventions: Device: No passive bending function; Device: Passive bending function

• Registration Number: NCT00518349
• Lead Sponsor: Norwegian Department of Health and Social Affairs

Brief Summary

A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Detailed Description

Results from the first prototype evaluation has been published.Modifications are presently evaluated.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Primary Completion: 2007-12
• Study Completion: 2009-12
• Results First Submitted: 2013-01-07
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Results First Posted: 2018-05-29
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients referred for routine outpatients colonoscopy

Exclusion Criteria

• Pregnant women
• Age below 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard colonoscope	No passive bending function	Colonoscopy using standard colonoscope with no passive bending function
Prototype colonoscope	Passive bending function	Colonoscopy using prototype colonoscope with passive bending function

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Pain Experienced During Colonoscopy	Pain experienced during colonoscopy	The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).

Trial Locations

Locations (1)

Gastroenterology section, Dept. of Medicine, Telemark Hospital; 🇳🇴 Skien, Norway