Bowel Preparation
Conditions
Keywords
bowel preparation quality
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.
Interventions
DRUGPEG-Mizone
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.
DRUGPEG-ELS
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.
Sponsors
Ningbo No. 1 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.
Exclusion criteria
1. Patients with constipation; 2. Patients with congestive heart failure; 3. Patients with a history of kidney disease; 4. Patients with a history of poor intestinal preparation; 5. Pregnant / lactating women; 6. Patients without informed consent; 7. Allergic or intolerant to any research drug; 8. Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon; 9. Patients with a history of inflammatory bowel disease; 10. Significant electrolyte anomalies, including phosphorus, sodium, potassium, calcium, chloride and magnesium; 11. History of colorectal resection； 12. Patients with diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Bowel Preparation | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 3 days | Including Electrolyte disorders requiring clinical treatment, etc. |
| patient tolerability of bowel preparation | 1 Day of colonoscopy | 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). |
Countries
China
Outcome results
None listed