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Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet

NCT00748293 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2008-09-08

No results posted yet for this study

Summary

Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to 2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation with 2000 ml PEG-ELS. Poor patient compliance, however, is the main hurdle to complete ingestion of 2000 ml PEG-ELS not only for subjects with lower body weight but also for those with normal BMI or body weight.The main cause of poor patient compliance includes abdominal pain, bloating, nausea or vomiting during ingestion of cleansing fluid.Though diet restriction with low-fiber diet is always advised to every screen before colonoscopy, the extent of diet restriction is widely variable and thus influences the degree of colon cleansing.

With commercialized low-residue diet (CLRD), diet restriction will be well controlled and variability of colon cleansing can be minimized such that guarantee a colonoscopy with good quality. In this RCT, we will compare the compliance of screen during colon cleansing using different protocol: namely 2000 ml PEG-ELS vs. 1500 ml plus low-residue diet.

Conditions

  • Colonoscopy
  • Colon Cleansing
  • Low-Reside Diet

Interventions

OTHER

Low-residue diet

Commercialized (not yet marketed)low-residue diet

Sponsors & Collaborators

  • Taipei Medical University Hospital

    collaborator OTHER

  • E-DA Hospital

    collaborator OTHER

  • Buddhist Tzu Chi General Hospital

    collaborator OTHER

  • En Chu Kong Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Han-Mo Chiu, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748293 on ClinicalTrials.gov