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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bowel Cleansing; Good Taste

Intervention / Treatment
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* Drug: Mannitol
* Drug: Polyethylene glycol electrolyte


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol<br>Use of oral 1L Mannitol for remediation of intestinal uncleanliness | Drug: Mannitol<br>* 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.<br>|
| Active Comparator: Polyethylene glycol electrolyte<br>Use of oral 1L PEG for remediation of intestinal uncleanliness | Drug: Polyethylene glycol electrolyte<br>* 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.<br>|

What is the study measuring?
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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 |