Mizone vs Water for Bowel Preparation.

Study Overview
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Brief Summary
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In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000) and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in subjects undergoing colonoscopy.

Official Title
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The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: PEG-Mizone
* Drug: PEG-ELS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study. Exclusion Criteria: Patients with constipation; Patients with congestive heart failure; Patients with a history of kidney disease; Patients with a history of poor intestinal preparation; Pregnant / lactating women; Patients without informed consent; Allergic or intolerant to any research drug; Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon; Patients with a history of inflammatory bowel disease; Significant electrolyte anomalies, including phosphorus, sodium, potassium, calcium, chloride and magnesium; History of colorectal resection； Patients with diabetes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: PEG-Mizone prep<br>The evening before the colonoscopy: The patients who are randomized to the  PEG-Mizone prep  arm will drink single dose of 60g Polyethylene Glycol (PEG-4000) with 0.6L Mizone+0.4L water at a rate of 250 ml every 15 min. On the day of the colonoscopy: The patients who are randomized to the  PEG-Mizone prep  arm will drink single dose of 120g Polyethylene Glycol (PEG-4000) with 1.2L Mizone+0.8L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. | Drug: PEG-Mizone<br>* The evening before the colonoscopy:60gPEG-4000 was mixed with 0.6LMizone and 0.4L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 1.2LMizone and 0.8L water.<br>|
| Active Comparator: PEG-ELS prep<br>The evening before the colonoscopy: In the PEG-ELS prep group, all the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min. On the day of the colonoscopy: all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. | Drug: PEG-ELS<br>* The evening before the colonoscopy:60gPEG-4000 was mixed with 1L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 2L water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Bowel Preparation | The OBPS，a scoring system with scores between 0 and 14, where 0 is the best score，divides the colon into 3 segments (right, transverse and rectosigmoid colon); each is scored from 0-4 (0=excellent, If it is necessary to suction liquid stool to adequately see the colonic wall, a score of 2 (fair) is given; if it is necessary to wash and to suction, a score of 3 (poor) is given. The remaining scores fall into place around these anchors. ). A score 0-2 is added to indicate the total amount of luminal fluid.(0=The total amount of fluid in the colon is very small,1=a moderate volume of fluid overall in the colon,2=a large volume of fluid overall in the colon) | 1 Day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate | Including Electrolyte disorders requiring clinical treatment, etc. | 3 days | 
| patient tolerability of bowel preparation | On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience with a modified 5-point Likert scale for ease of use (score 5-1: very easy, easy, tolerable, difficult or very difficult). | 1 Day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel preparation quality