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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-Mizone prep | Experimental | 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. |
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| PEG-ELS prep | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-Mizone | Drug | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo No. 1 Hospital | Ningbo | Zhejiang | 315000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36028915 | Derived | Zhang Z, Gao H, Yuan X, Liu C, Bao Z, Yu S, Xie H, Wang W, Xie J, Xu L. The efficacy and tolerability of sports drink versus water in bowel preparations: a randomised controlled study. Trials. 2022 Aug 26;23(1):709. doi: 10.1186/s13063-022-06658-2. |
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| PEG-ELS | Drug | 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. |
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| 1 Day of colonoscopy |