Effectiveness of Mannitol Versus Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial

Effectiveness of 1L Mannitol Versus 1L Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial

For patients with inadequate bowel preparation, current guidelines recommend either remedial measures or rescheduling the endoscopy, but previous surveys have found that approximately 30% of patients do not follow medical advice to reschedule the examination if it is rescheduled, while those who take remedial measures on the same day are more compliant, so remedial measures may be a better option than rescheduling the examination. As for the remedy regimen, it has been demonstrated that oral PEG is superior to the enema regimen in terms of bowel cleansing, but PEG is very resistant to be taken by most patients due to its poor taste and the larger doses required, resulting in poor bowel preparation and poor compliance. In contrast, oral mannitol has the advantages of small dose and good taste, and patient compliance may be higher.

Study Overview

• Status: Recruiting
• Conditions: Bowel Cleansing; Good Taste
• Intervention / Treatment: Drug: Mannitol; Drug: Polyethylene glycol electrolyte

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei f Xu; Phone Number: +8613486659126; Email: xulei22@163.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Recruiting
      • Ningbo First Hospital
      • Contact: Lei Xu, MD; Phone Number: +86-13486659126; Email: xulei22@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-75 years with a pre-first colonoscopy bowel cleanliness of less than 2 points in any segment of the bowel.

Exclusion Criteria:

- (1) Pregnant women. (2) History of colorectal surgery. (3) Patients with acute exacerbation of inflammatory bowel disease. (4) Patients with severe medical conditions that make them unsuitable for colonoscopy.

(5) Patients with known allergy to mannitol/PEG. (6) Patients who refuse to sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mannitol; Use of oral 1L Mannitol for remediation of intestinal uncleanliness	Drug: Mannitol; Mannitol, as an osmotic laxative, increases the colloid osmotic pressure in the intestinal lumen, which results in a hyperosmolar state in the intestine, thus allowing easy elimination of stools.
Active Comparator: Polyethylene glycol electrolyte; Use of oral 1L PEG for remediation of intestinal uncleanliness	Drug: Polyethylene glycol electrolyte; Polyethylene glycol electrolyte is an inert polymer that cannot be absorbed by the body itself. Due to its high permeability, it retains water in the intestinal tract, increasing the amount of fluid retained in the intestine and softening the stool, thus acting as a diuretic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel cleanliness	The BBPS scoring method, defined as a score of ≥2 for each bowel segment, was used to consider the preparation adequate.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' feelings	Patients' perceptions of the taste and ease of use of the two drugs.	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' willingness to take such measures again.	Patient's willingness to take the same medication before the next colonoscopy.	1 hour

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: MPEG1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No