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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05912114
Enrollment
134
Registered
2023-06-22
Start date
2023-06-10
Completion date
2024-12-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cleansing; Good Taste

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.

Interventions

DRUGMannitol

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.

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.

Sponsors

Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bowel cleanliness1 hourThe BBPS scoring method, defined as a score of ≥2 for each bowel segment, was used to consider the preparation adequate.

Secondary

MeasureTime frameDescription
Patients' feelings1 hourPatients' perceptions of the taste and ease of use of the two drugs.

Other

MeasureTime frameDescription
Patients' willingness to take such measures again.1 hourPatient's willingness to take the same medication before the next colonoscopy.

Countries

China

Contacts

Primary ContactLei f Xu
xulei22@163.com+8613486659126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026