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Recruiting NCT06675227

Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation

No phase Interventional Bowel Preparation Before Colonoscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electrolyte beverages.
Who it may be relevant to
Registry conditions: Bowel Preparation Before Colonoscopy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • The Boston Bowel Preparation Scale [Time frame: From enrollment to the time point when patients finished colonscopy (within a week).]
Secondary outcome measures (2)
  • The Palatability [Time frame: From enrollment to the time point when patients finished colonscopy(within a week).]
  • Lesion Detection Rate [Time frame: From enrollment to the time point when patients finished colonscopy (within a week).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • Army Medical Center — Chongqing

Identifiers

NCT: NCT06675227 · 20240924 · 2022XLC05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗