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

Sponsor
Ningbo No. 1 Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05912114
Collaborator
(none)
134
1
2
18.7
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of 1L Mannitol Versus 1L Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial
Actual Study Start Date :
Jun 10, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Patients' feelings [1 hour]

    Patients' perceptions of the taste and ease of use of the two drugs.

Other Outcome Measures

  1. Patients' willingness to take such measures again. [1 hour]

    Patient's willingness to take the same medication before the next colonoscopy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ningbo first hospital Ningbo Zhejiang China 315000

Sponsors and Collaborators

  • Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ningbo No. 1 Hospital
ClinicalTrials.gov Identifier:
NCT05912114
Other Study ID Numbers:
  • MPEG1.0
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023