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Completed

NCT Number: NCT04247386

Mizone vs Water for Bowel Preparation.

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.

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Key information

Conditions

Bowel Preparation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo No. 1 Hospital

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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.

Primary outcomes

  1. 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

  1. Adverse event rate

    Time frame: 3 days

    Including Electrolyte disorders requiring clinical treatment, etc.

  2. patient tolerability of bowel preparation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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