Comparison of Electrolyte Beverages and Water As Solvents for Bowel Preparation
- Conditions
- Bowel Preparation Before Colonoscopy
- Registration Number
- NCT06675227
- Lead Sponsor
- Third Military Medical University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2766
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Boston Bowel Preparation Scale 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 Outcome Measures
Name Time Method The Palatability 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.
Lesion Detection Rate 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.
Trial Locations
- Locations (1)
Army Characteristic Medical Center
🇨🇳Chongqing, Chongqing, China