The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- PEG-Mizone
- Conditions
- Bowel Preparation
- Sponsor
- Ningbo No. 1 Hospital
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Quality of Bowel Preparation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
PEG-Mizone prep
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.
Intervention: PEG-Mizone
PEG-ELS prep
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.
Intervention: PEG-ELS
Outcomes
Primary Outcomes
Quality of Bowel Preparation
Time Frame: 1 Day of colonoscopy
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)
Secondary Outcomes
- Adverse event rate(3 days)
- patient tolerability of bowel preparation(1 Day of colonoscopy)