Mizone vs Water for Bowel Preparation.

Ningbo No. 1 Hospital270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

270

Conditions

Bowel Preparation

Interventions

PEG-MizoneDRUG

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.

PEG-ELSDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ningbo No. 1 Hospital

Ningbo, Zhejiang, China

Outcomes

Primary Outcomes

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)

Time frame: 1 Day of colonoscopy

Secondary Outcomes

Adverse event rate

Including Electrolyte disorders requiring clinical treatment, etc.

Time frame: 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).

Time frame: 1 Day of colonoscopy

Data from ClinicalTrials.gov

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