- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155415
A Prospective Single-Blinded Randomized Trial Comparing Colonoscopic Preparation at Different Time
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is the leading cause of cancer death not only in the Western countries but also in Taiwan. It is now the third leading cause of cancer mortality both in men and women in Taiwan. Previous studies revealed early detection of adenomatous polyp, the precursor lesion of CRC, plays a pivotal role in CRC prevention and removal of these lesions was proven to reduce CRC mortality. Fecal occult blood test (FOBT) is now the standard mass screening modality and colonoscopy is the standard procedure of choice if FOBT was positive. Nevertheless, colonoscopy is now gradually accepted as one of the powerful tool for colorectal cancer screening. Not only for survey after positive fecal test, it is also applied as primary screening modality for CRC screening.Colon cleansing before colonoscopy thus becomes critically important and inadequate preparation may lead to low diagnostic yield with missed lesions, increased risk of complication and prolonged procedure time. Though the importance of good colon preparation can not be over-emphasized, diet control before colonoscopy and ingestion of large amount of lavage solution remain a significant hurdle to overcome and investigators continue to seek for the ideal colon preparation with respect to quality and examinee satisfaction.
After the introduction of polyethylene glycol electrolyte lavage solution (PEG-ELS) for bowel preparation before colon procedures, its safety was well documented and the efficacy of colon cleansing was proven efficient. The timing of ingesting PEG-ELS is different between institutes and some ingest PEG-ELS as a whole at the night before colonoscopic examination and some ingested in split-dose manner which ingest half of the solution at previous night and remaining on the day of examination. Some institutes ask examinee to receive lavage solution on the day of examination. The manufacturer advices start taking medication on the day before the investigation according to their printed instruction on the package of PEG-ELS. Though there were a lot of studies that conducted to describe the result of colon cleansing in different fashion, the result is still controversial.
This prospective, randomized, single-blinded trail evaluated and compared the efficacy of colon preparation at two timing of colon preparation, namely, in previous night or on the day of colonoscopic examination. In this study, we enrolled those who have already colon neoplasia detected during voluntary routine health check-up and received second colonoscopic examination for either elective polypectomy or endoscopic mucosectomy (EMR). We used not only the cleansing condition as a reference of adequate preparation; we also compared the diagnostic yield of lesion number as an objective comparator between these two methods.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Those who had colon neoplasia detected at screening colonoscopy and requiring polypectomy or mucosectomy
Exclusion Criteria:
- those who used anti-platelet agents or anticoagulants that can not be stopped,
- those who had minute polyps detected that had been removed at screening colonoscopy,
- those who had invasive cancer that require surgical intervention,
- those who cannot complete total colonoscopy for any reason at health check-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cleansing level of colon and detected lesion number during colonoscopy
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Collaborators and Investigators
Investigators
- Principal Investigator: Han-Mo Chiu, M.D., National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9461700305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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