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

Study Overview
=================
Brief Summary
-----------------
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.

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

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

Conditions
-----------------
Bowel Preparation, Colonoscopy

Intervention / Treatment
-----------------
* Drug: Low volume PEG
* Drug: high volume PEG


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: High volume PEG<br>Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation. | Drug: high volume PEG<br>* high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times<br>|
| Active Comparator: Low volume PEG with low residual meals<br>Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation. | Drug: Low volume PEG<br>* low volume polyethylene glycol 2 liter one time<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel preparation | Quality of bowel preparation is assessed using Ottawa bowel preparation scale. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Tolerability of bowel preparation regimen is assessed by patient questionnaire. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, bowel preparation, polyethylene glycol, low residue meal