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Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06675227
Acronym
EBSBP-01
Enrollment
2766
Registered
2024-11-05
Start date
2024-11-11
Completion date
2025-12-31
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation Before Colonoscopy

Keywords

bowel preparation, Electrolyte Beverages

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.

Interventions

DIETARY_SUPPLEMENTelectrolyte beverages

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

Sponsors

The thirteenth people's hospital of Chonqing
CollaboratorUNKNOWN
Fuling people's hospital of Chongqing
CollaboratorUNKNOWN
Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The Boston Bowel Preparation ScaleFrom 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

MeasureTime frameDescription
The PalatabilityFrom 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 RateFrom 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

MeasureTime frameDescription
Patient Willingness to RepeatFrom 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.
Bowel Preparation TimeFrom 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.

Countries

China

Contacts

Primary ContactKun Xv
vdtong@163.com13500321218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026