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A Prospective Single-Blinded Randomized Trial Comparing Colonoscopic Preparation at Different Time

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155415
First received: September 8, 2005
Last updated: December 1, 2008
Last verified: September 2005
  Purpose

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.


Condition Intervention
Colonoscopy
Colon Neoplasm
Behavioral: Different timing of taking polyethylene glycol(PEG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Cleansing level of colon and detected lesion number during colonoscopy

Estimated Enrollment: 120
Study Start Date: April 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Those who had colon neoplasia detected at screening colonoscopy and requiring polypectomy or mucosectomy

Exclusion Criteria:

  1. those who used anti-platelet agents or anticoagulants that can not be stopped,
  2. those who had minute polyps detected that had been removed at screening colonoscopy,
  3. those who had invasive cancer that require surgical intervention,
  4. those who cannot complete total colonoscopy for any reason at health check-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155415

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Han-Mo Chiu, M.D. National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155415     History of Changes
Other Study ID Numbers: 9461700305
Study First Received: September 8, 2005
Last Updated: December 1, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Colonoscopy
Polyethylene glycol(PEG)
Colon neoplasm
Colon cleansing
Timing

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014