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NCT Number: NCT06675227

Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation

Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process.

The aim of this study is to test whether Electrolyte Beverages as solvents can improve the cleanness of bowel preparation and the satisfaction of patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Army Medical Center

Chongqing, Chongqing Municipality, 400042, China

Location status: Recruiting

Location contact

WeiDong Tong, MD

CONTACT

[email protected]

+862368729356

About this study

The application of electronic colonoscopy has shown a significant upward trend in the diagnosis, screening, and health check-ups for colorectal diseases.

To clean the colon, patients must consume several liters of bowel preparation solution in a short period before the procedure.

However, a significant number of patients experience nausea or even vomiting, preventing them from completing the recommended dose, resulting in suboptimal bowel preparation and affecting the colonoscopy process.

Therefore, the investigators have designed a protocol that uses sugar-free electrolyte beverages instead of regular drinking water as a solvent for the laxative solution. By improving the taste of the oral solution and increasing the electrolyte content, the investigators aim to enhance patient compliance with colonoscopy preparation and ultimately assess the effectiveness of bowel cleansing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy individuals or those with mild or well-controlled chronic diseases.
  • Patients scheduled for outpatient colonoscopy.
  • Patients prescribed sodium phosphate or polyethylene glycol for bowel preparation.
  • Willing to participate and sign the informed consent form.
  • Age ≥18 years
  • ECOG performance status <2

Exclusion criteria

  • Patients who refuse to participate in the study.
  • Patients requiring enema preparation.
  • Uncontrolled hypertension.
  • Patients with diabetes.
  • Pregnant patients.
  • Suspected bowel obstruction.
  • Risk of aspiration.
  • Patients with severe ulcerative colitis, gastric retention, bowel perforation, toxic colitis, or megacolon.
  • Patients with severe systemic diseases (including NYHA class 3-4 heart failure, Child-Pugh class C liver failure).
  • Patients with a known allergy to polyethylene glycol.
  • Patients with a history of major gastrointestinal surgery or any other conditions that may interfere with study outcomes or adherence.

Treatment and study plan

electrolyte beverages

Dietary Supplement

Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process.

Primary outcomes

  1. The Boston Bowel Preparation Scale

    Time frame: From enrollment to the time point when patients finished colonscopy (within a week).

    The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation.

Secondary outcomes

  1. The Palatability

    Time frame: From enrollment to the time point when patients finished colonscopy(within a week).

    The palatability of different bowel preparation regimens will be assessed using a 4-point scale. The scoring system is as follows: 1 = very poor, 2 = poor, 3 = good, 4 = very good. Each participant's score will be collected and statistically analyzed.

  2. Lesion Detection Rate

    Time frame: From enrollment to the time point when patients finished colonscopy (within a week).

    The proportion of polyps, tumors, inflammatory bowel disease, and diverticulosis detected during colonoscopy under different bowel preparation regimens will be recorded. The detection rate will be expressed as a percentage, and differences between the groups will be analyzed.

Other outcomes

  1. Patient Willingness to Repeat

    Time frame: From enrollment to the time point before colonscopy(within a week).

    The willingness of patients to undergo a repeat colonoscopy after the procedure will be recorded and analyzed. This will be quantified using a Yes/No format, and the proportion of willingness in each group will be calculated.

  2. Bowel Preparation Time

    Time frame: From enrollment to the time point before colonscopy(within a week).

    The total time (in minutes) required for each patient to complete 2000 ml of bowel preparation solution will be recorded, and the average time and standard deviation will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Collaborators

  • Fuling people's hospital of Chongqing
  • The thirteenth people's hospital of Chonqing

Registry information

Official study title

Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation: A Single-Blind, Prospective, Multicenter Randomized Controlled Trial

Acronym: EBSBP-01

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Mar 20, 2025

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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