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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)
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.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

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.

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.

  1. 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.

  1. First posted12 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionSep 2005
  4. Study completionSep 2005

Resources

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
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

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.

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