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

Not Applicable

Recruiting

• Conditions: Bowel Cleansing; Good Taste
• Interventions: Drug: Polyethylene glycol electrolyte; Drug: Mannitol

• Registration Number: NCT05912114
• Lead Sponsor: Ningbo No. 1 Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-10
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyethylene glycol electrolyte	Polyethylene glycol electrolyte	Use of oral 1L PEG for remediation of intestinal uncleanliness
Mannitol	Mannitol	Use of oral 1L Mannitol for remediation of intestinal uncleanliness

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patients' feelings	1 hour	Patients' perceptions of the taste and ease of use of the two drugs.

Trial Locations

Locations (1)

Ningbo first hospital; 🇨🇳 Ningbo, Zhejiang, China