ColonoscopyNCT00155415
A Prospective Single-Blinded Randomized Trial Comparing Colonoscopic Preparation at Different Time
A study testing Different timing of taking polyethylene glycol(PEG) in people with Colonoscopy and Colon Neoplasm, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Colonoscopy, Colon Neoplasm
- What is being tested?
- Different timing of taking polyethylene glycol(PEG)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2005to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who had colon neoplasia detected at screening colonoscopy and requiring polypectomy or mucosectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read the 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.
- Conditions
- Colonoscopy, Colon Neoplasm
- Being tested
- Different timing of taking polyethylene glycol(PEG)
- Keywords
- Colonoscopy, Polyethylene glycol(PEG), Colon neoplasm, Colon cleansing, Timing
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different timing of taking polyethylene glycol(PEG)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleansing level of colon and detected lesion number during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Han-Mo Chiu, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155415
- Sponsor's protocol ID
- 9461700305
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 2 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Blinded Randomized Trial Comparing Colonoscopic Preparation at Different Time
- ClinicalTrials.gov ID
- NCT00155415
- Acronym / sponsor ID
- 9461700305
- Conditions
- Colonoscopy, Colon Neoplasm
- Keywords
- Colonoscopy, Polyethylene glycol(PEG), Colon neoplasm, Colon cleansing, Timing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who had colon neoplasia detected at screening colonoscopy and requiring polypectomy or mucosectomy
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different timing of taking polyethylene glycol(PEG) | Behavioural | – |
Primary outcome
Cleansing level of colon and detected lesion number during colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Mo Chiu, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different timing of taking polyethylene glycol(PEG) in people with Colonoscopy and Colon Neoplasm, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleansing level of colon and detected lesion number during colonoscopy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2008.