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

NCT00155415 | Completed

• 1 other identifier: 9461700305
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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

Keywords

Colonoscopy; Polyethylene glycol(PEG); Colon neoplasm; Colon cleansing; Timing

Outcome Measures

Primary Outcomes (1)

• Cleansing level of colon and detected lesion number during colonoscopy

Interventions

Different timing of taking polyethylene glycol(PEG) BEHAVIORAL

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Han-Mo Chiu, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: December 2, 2008

Record last verified: 2005-09

Locations

TW (1)