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Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation (LOWPEG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University
ClinicalTrials.gov Identifier:
NCT01568814
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: January 2012
History of Changes
  Purpose

Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.


Condition Intervention Phase
Bowel Preparation
Colonoscopy
 Drug: Low volume PEG
Drug: high volume PEG
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Quality of bowel preparation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Quality of bowel preparation is assessed using Ottawa bowel preparation scale.


Secondary Outcome Measures:
  • Tolerability [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Tolerability of bowel preparation regimen is assessed by patient questionnaire.


Enrollment: 188
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: High volume PEG
Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.
 Drug: high volume PEG
high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times
Active Comparator: Low volume PEG with low residual meals
Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.
 Drug: Low volume PEG
low volume polyethylene glycol 2 liter one time

Detailed Description:

We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.

Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy
  • Breast feeding
  • Prior history of surgical large bowel resection
  • Severe medical condition such as severe cardiac
  • Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
  • Drug addiction or major psychiatric illness
  • Suspected bowel obstruction or ileus
  • Allergy to PEG
  • Refusal of consent to participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568814

Locations
Korea, Republic of
Haeundae Paik Hospital, Inje University School of Medicine
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
  More Information

No publications provided

Responsible Party: Eun Hee Seo, MD, Principal investigator, Inje University
ClinicalTrials.gov Identifier: NCT01568814     History of Changes
Other Study ID Numbers: 1.0-A2012
Study First Received: March 29, 2012
Last Updated: March 30, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
colonoscopy
bowel preparation
polyethylene glycol
low residue meal

ClinicalTrials.gov processed this record on June 18, 2013