Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155415
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2005-09-08
Brief Title:
A Prospective Single-Blinded Randomized Trial Comparing Colonoscopic Preparation at Different Time
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer CRC is the leading cause of cancer death not only in the Western countries but also in Taiwan 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 screeningColon 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
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 screeningColon 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None