Improving Quality of Colonoscopy Using a 3D-imager

Phase 3CompletedNCT00519129

Sorlandet Hospital HF800 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

800

Conditions

Pain During Colonoscopy

Interventions

3D-imagerDEVICE

3D-imager vs fluoroscopy during coloscopy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sorlandet Sykehus HF

Kristiansand, Norway

Outcomes

Primary Outcomes

pain during coloscopy

Time frame: instant

Time used to reach the coecum

Time frame: instant

Secondary Outcomes

coecum-intubation rate

Time frame: instant

level achieved when the coecum can not be reached

Time frame: instant

Need for assistance by a colleague

Time frame: instant

Need for analgetics

Time frame: instant

Pain during the first 24 hours after coloscopy

Time frame: 24 hours

Polyp detection rate

Time frame: instant

Data from ClinicalTrials.gov

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