Does Endoscope Position Detecting Unit Facilitate a Complete Colonoscopy Examination (UPD-3)
Recruitment status was: Recruiting
As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is highly variable and dependent on individual experience. Colonic looping is the commonest cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological imaging technique to provide real time, three-dimensional image and position of the colonoscope during the procedure. It may facilitate straightening of colonic loops and hence cecal intubation.
The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across endoscopists of all levels of experience by making use of the newly developed Endoscopy Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.
The investigators propose to conduct a prospective randomized controlled trial to compare the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance. Colonoscopies performed by endoscopists with different level of experience will be randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation (PCS) containing propofol and alfentanil will be given to all patients. The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy in trainees.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Does Endoscope Position Detecting Unit Facilitate Caecal Intubation? A Randomized Controlled Trial|
- caecal intubation rate [ Time Frame: 10minutes in average after starting the procedure ]Caeal intubation is the landmark for complete colonoscopy. Caecal intubation would be documented after each procedure. The caecal intubation rate with or without UPD guidance would be compared. The result would provide information whether the UPD device can faciliate complete colonoscopy.
- Caecal intubation time [ Time Frame: 10 minutes in average after starting the procedure ]Comparison of caecal intubaton time between UPD guided and non-UPD guided group would provide information on whether UPD device faciliate complete colonoscopy.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: UPD guided group
Both the colonoscopist and assistant will be viewing the imager screen during the whole procedure.
Procedure: UPD guidance
A real time, three-dimensional image and position of the colonoscope would be provided to the endoscopist during the procedure.
Other Name: Magnetic endoscope imaging (MEI)
No Intervention: non-UPD guided group
Conventional colonoscopy would be done without image guidance.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01434199
|China, Hong Kong|
|Alice Ho Miu Ling Nethersole Hospital|
|Hong Kong, Hong Kong, China|
|Prince of Wales Hospital|
|Hong Kong, Hong Kong, China|
|Principal Investigator:||Sophie SF Hon, MD||Chinese University of Hong Kong|