Mizone vs Water for Bowel Preparation.

NCT04247386 | Completed

• 1 other identifier: PEG-1.0
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Keywords

bowel preparation quality

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Adverse event rate

  3 days

• patient tolerability of bowel preparation

  1 Day of colonoscopy

Study Arms (2)

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.

Drug: PEG-Mizone

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.

Drug: PEG-ELS

Interventions

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.

PEG-Mizone prep

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.

PEG-ELS prep

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.

You may not qualify if:

• 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;
• History of colorectal resection；
• Patients with diabetes.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo No. 1 Hospital

Ningbo, Zhejiang, 315000, China

Location

Related Publications (1)

• 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.

  PMID: 36028915 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: January 30, 2020
• Study Start: December 25, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 31, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

CN (1)