Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation (LOWPEG)
|ClinicalTrials.gov Identifier: NCT01568814|
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : April 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bowel Preparation Colonoscopy||Drug: Low volume PEG Drug: high volume PEG||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568814
|Korea, Republic of|
|Haeundae Paik Hospital, Inje University School of Medicine|
|Busan, Korea, Republic of, 612-030|