Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients (PEG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Kangbuk Samsung Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Soon Chun Hyang University
Kyunghee University
Hanyang University
Information provided by (Responsible Party):
Dong Il Park, M.D, Ph.D., Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT01528098
First received: February 3, 2012
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.


Condition
Intestine; Complaints

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy of Bisacodyl Given as Part of a Polyethylene Glycol-based Bowel Preparation Prior to Colonoscopy in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Kangbuk Samsung Hospital:

Primary Outcome Measures:
  • The efficacy of bowel preparation [ Time Frame: one day (after colonoscopy) ] [ Designated as safety issue: No ]
    Ottawa scale


Secondary Outcome Measures:
  • Patient's compliance and acceptability [ Time Frame: one day (after injestion of preparation solution) ] [ Designated as safety issue: No ]
    acceptability, Visual Analogue Scale

  • Patient's compliance and acceptability (2) [ Time Frame: one day (after injestion of preparation solution) ] [ Designated as safety issue: No ]
    stress for ingestion, Stress 0(not) - 4(severe)

  • Patient's compliance and acceptability (3) [ Time Frame: one day (after colonoscopy) ] [ Designated as safety issue: No ]
    willingness for re-evaluation, 0(very willing) - 4(some)


Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
PEG plus bisacodyl
Those who taken PEG 4L + bisacodyl 10mg
PEG 4L
Those who taken PEG 4L alone

Detailed Description:

Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Hospitalized patients for colonoscopy in university hospital.

Criteria

Inclusion Criteria:

  • Hospitalized patients for colonoscopy

Exclusion Criteria:

  • age under 20 years or over 80 years
  • major psychiatric illness
  • known allergy to PEG
  • serious condition- severe cardiac, renal, or metabolic diseases
  • partial colon resection
  • current acute exacerbation of chronic inflammatory bowel disease
  • functional constipation defined by Rome III diagnostic criteria
  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: NCT01528098

Contacts
Contact: Dong Il Park, professor 82-2-2001-2059 diksmc.park@samsung.com

Sponsors and Collaborators
Kangbuk Samsung Hospital
Soon Chun Hyang University
Kyunghee University
Hanyang University
Investigators
Principal Investigator: Dong Il Park, Professor Kangbuk Samsung Hospital
  More Information

No publications provided

Responsible Party: Dong Il Park, M.D, Ph.D., Associate professor, Department of Internal Medicine, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT01528098     History of Changes
Other Study ID Numbers: PEGPD
Study First Received: February 3, 2012
Last Updated: February 20, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Kangbuk Samsung Hospital:
polyethylene glycol
bisacodyl

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014