Does Endoscope Position Detecting Unit Facilitate a Complete Colonoscopy Examination (UPD-3)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms |
Procedure: UPD guidance |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Comparison of caecal intubaton time between UPD guided and non-UPD guided group would provide information on whether UPD device faciliate complete colonoscopy.
| Estimated Enrollment: | 870 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18 years or above
- American Society of Anaesthesiologist (ASA) grading I-III
- Scheduled for elective colonoscopy
Exclusion Criteria:
- Previous colonic resection
- Refuse to consent to participate
- History of allergy to propofol or alfentanil
- Has a pacemaker in situ
- Pregnant lady
Contacts and Locations| Contact: Sophie SF Hon, MD | 852-2632 1495 | honsf@surgery.cuhk.edu.hk |
| Contact: James YW Lau, MD | 852-2632 1441 | laujyw@surgery.cuhk.edu.hk |
| China, Hong Kong | |
| Prince of Wales Hospital | Recruiting |
| Hong Kong, Hong Kong, China | |
| Contact: Sophie SF Hon, MD 852-2632 1495 honsf@surgery.cuhk.edu.hk | |
| Alice Ho Miu Ling Nethersole Hospital | Recruiting |
| Hong Kong, Hong Kong, China | |
| Contact: Sophie SF Hon, MD 852-2632 1495 honsf@surgery.cuhk.edu.hk | |
| Principal Investigator: | Sophie SF Hon, MD | Chinese University of Hong Kong |
More Information
Publications:
| Responsible Party: | Hon Sok Fei, Associate consultant, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01434199 History of Changes |
| Other Study ID Numbers: | CRE-2011.125-T |
| Study First Received: | June 20, 2011 |
| Last Updated: | September 13, 2011 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
magnetic endoscope imaging colonoscopy caecal intubation |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013