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
  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:


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
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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 October 23, 2014