Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy

Study Overview
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Brief Summary
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Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG. The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Detailed Description
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Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort. The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Official Title
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Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: High volume split-dose PEG
* Drug: 2 sachets of picosulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms Exclusion Criteria: pregnancy, breast feeding, prior history of surgical large bowel resection, severe medical condition such as severe cardiac, hepatic, or renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)), significant gastric paresis or gastric outlet obstruction or ileus, known or suspected bowel obstruction or perforation, drug addiction or major psychiatric illness, allergy to PEG and refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: High volume Split-dose PEG<br>Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation | Drug: High volume split-dose PEG<br>* High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy<br>* Other names: Polyethylene glycol(Colyte);|
| Active Comparator: 2 sachets of picosulfate<br>Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy. | Drug: 2 sachets of picosulfate<br>* 2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy<br>* Other names: sodium picosulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of bowel preparation | Quality of bowel preparation using Ottawa bowel preparation scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Tolerability of bowel preparation regimen is assessed by patient questionnaire. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation, colonoscopy, polyethylene glycol, picosulfate