Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation

NCT06675227 | Recruiting DMC

• 2 other identifiers: 202409242022XLC05
• Study Type: interventional
• Target: 2,766
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation Before Colonoscopy

Keywords

bowel preparation; Electrolyte Beverages

Outcome Measures

Primary Outcomes (1)

• The Boston Bowel Preparation Scale

  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.

  From enrollment to the time point when patients finished colonscopy (within a week).

Secondary Outcomes (2)

• The Palatability

  From enrollment to the time point when patients finished colonscopy(within a week).

• Lesion Detection Rate

  From enrollment to the time point when patients finished colonscopy (within a week).

Other Outcomes (2)

• Patient Willingness to Repeat

  From enrollment to the time point before colonscopy(within a week).

• Bowel Preparation Time

  From enrollment to the time point before colonscopy(within a week).

Study Arms (2)

Drinking Water Group

NO INTERVENTION

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

Electrolyte Beverages Group

EXPERIMENTAL

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

Dietary Supplement: electrolyte beverages

Interventions

electrolyte beverages DIETARY_SUPPLEMENT

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

Electrolyte Beverages Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead
• The thirteenth people's hospital of Chonqing: collaborator
• Fuling people's hospital of Chongqing: collaborator

Study Sites (1)

Army Medical Center

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Study Officials

• Weidong Tong, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Xv

CONTACT

13500321218; vdtong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: November 11, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CN (1)