Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation

NCT ID: NCT06675227

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2766 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2025-12-31

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.

Conditions

Bowel Preparation Before Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Drinking Water Group

This group will apply the ordinary drinking water as the solvents for 2L PEG to dissolve.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Electrolyte Beverages Group

This group will apply the electrolyte beverages(Alienergy) instead of ordinary drinking water as the solvents for 2L PEG to dissolve.

Group Type: EXPERIMENTAL

electrolyte beverages

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

electrolyte beverages

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The thirteenth people's hospital of Chonqing

UNKNOWN

Sponsor Role: collaborator

Fuling people's hospital of Chongqing

UNKNOWN

Sponsor Role: collaborator

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weidong Tong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weidong Tong, MD

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Locations

Army Medical Center

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kun Xv

Role: CONTACT

vdtong@163.com

13500321218

Facility Contacts

WeiDong Tong, MD

Role: primary

vdtong@163.com

+862368729356

Other Identifiers

2022XLC05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20240924

Identifier Type: -

Identifier Source: org_study_id