Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation (LOWPEG)
|Bowel Preparation Colonoscopy||Drug: Low volume PEG Drug: high volume PEG||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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|
- Quality of bowel preparation [ Time Frame: 2 months ]Quality of bowel preparation is assessed using Ottawa bowel preparation scale.
- Tolerability [ Time Frame: 2 months ]Tolerability of bowel preparation regimen is assessed by patient questionnaire.
|Study Start Date:||January 2012|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568814
|Korea, Republic of|
|Haeundae Paik Hospital, Inje University School of Medicine|
|Busan, Korea, Republic of, 612-030|