Mizone vs Water for Bowel Preparation.

NCT ID: NCT04247386

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-25

Study Completion Date

2020-08-31

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.

Detailed Description

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Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PEG-Mizone

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

PEG-ELS

Intervention Type 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.

Interventions

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PEG-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.

Intervention Type DRUG

PEG-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.

Intervention Type DRUG

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ningbo No. 1 Hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36028915 (View on PubMed)

Other Identifiers

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PEG-1.0

Identifier Type: -

Identifier Source: org_study_id

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