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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

N

Ningbo No. 1 Hospital

Status

Enrolling

Conditions

Bowel Cleansing; Good Taste

Treatments

Drug: Mannitol
Drug: Polyethylene glycol electrolyte

Study type

Interventional

Funder types

Other

Identifiers

NCT05912114
MPEG1.0

Details and patient eligibility

About

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.

Enrollment

134 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

134 participants in 2 patient groups

Mannitol
Experimental group
Description:
Use of oral 1L Mannitol for remediation of intestinal uncleanliness
Treatment:
Drug: Mannitol
Polyethylene glycol electrolyte
Active Comparator group
Description:
Use of oral 1L PEG for remediation of intestinal uncleanliness
Treatment:
Drug: Polyethylene glycol electrolyte

Trial contacts and locations

1

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Central trial contact

Lei f Xu

Data sourced from clinicaltrials.gov

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