Clinical trial NCT06675227: Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Official title: Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation: A Single-Blind, Prospective, Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Preparation Before Colonoscopy
Keywords: bowel preparation
Electrolyte Beverages
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
Collaborators: name: The thirteenth people's hospital of Chonqing
name: Fuling people's hospital of Chongqing
First posted: 2024-11-05
Enrollment: 2766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Boston Bowel Preparation Scale
timeFrame: From enrollment to the time point when patients finished colonscopy (within a week).
Secondary outcomes:
measure: The Palatability
timeFrame: From enrollment to the time point when patients finished colonscopy(within a week).
measure: Lesion Detection Rate
timeFrame: From enrollment to the time point when patients finished colonscopy (within a week).
Other outcomes:
measure: Patient Willingness to Repeat
timeFrame: From enrollment to the time point before colonscopy(within a week).
measure: Bowel Preparation Time
timeFrame: From enrollment to the time point before colonscopy(within a week).
Locations:
city: Chongqing
country: China
facility: Army Medical Center
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Weidong Tong, MD
role: PRINCIPAL_INVESTIGATOR
References: