Improving Quality of Colonoscopy Using a 3D-imager

Pain During Colonoscopy Clinical Trial

Official title:

Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519129
• Other study ID #: SSHF-Colon-1
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2007
• Last updated: August 17, 2011
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2011
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Description:

Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients referred for coloscopy on an out-patient basis

Exclusion Criteria:

• Pregnancy

• Pacemaker

• Lack of ability to understand information given

• Prior resection of the colon/rectum

• Demanding analgetics prior to start of procedure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain During Colonoscopy

Intervention

Device:
• 3D-imager
3D-imager vs fluoroscopy during coloscopy

Locations

Country	Name	City	State
Norway	Sorlandet 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	pain during coloscopy		instant	No
Primary	Time used to reach the coecum		instant	No
Secondary	coecum-intubation rate		instant	No
Secondary	level achieved when the coecum can not be reached		instant	No
Secondary	Need for assistance by a colleague		instant	No
Secondary	Need for analgetics		instant	No
Secondary	Pain during the first 24 hours after coloscopy		24 hours	No
Secondary	Polyp detection rate		instant	No