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Improving Quality of Colonoscopy Using a 3D-imager

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00519129
Enrollment
800
Registered
2007-08-22
Start date
2007-08-31
Completion date
2010-08-31
Last updated
2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain During Colonoscopy

Keywords

Pain, Patient satisfaction

Brief 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

Detailed description

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

Interventions

DEVICE3D-imager

3D-imager vs fluoroscopy during coloscopy

Sponsors

Sorlandet Hospital HF
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
pain during coloscopyinstant
Time used to reach the coecuminstant

Secondary

MeasureTime frame
Need for assistance by a colleagueinstant
Need for analgeticsinstant
coecum-intubation rateinstant
Polyp detection rateinstant
Pain during the first 24 hours after coloscopy24 hours
level achieved when the coecum can not be reachedinstant

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026