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

NCT ID: NCT05912114

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2024-12-31

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.

Conditions

Bowel Cleansing; Good Taste

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mannitol

Use of oral 1L Mannitol for remediation of intestinal uncleanliness

Group Type: EXPERIMENTAL

Mannitol

Intervention Type: DRUG

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

Use of oral 1L PEG for remediation of intestinal uncleanliness

Group Type: ACTIVE_COMPARATOR

Polyethylene glycol electrolyte

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo first hospital

Ningbo, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei f Xu

Role: CONTACT

xulei22@163.com

+8613486659126

Facility Contacts

Lei Xu, MD

Role: primary

xulei22@163.com

+86-13486659126

Other Identifiers

MPEG1.0

Identifier Type: -

Identifier Source: org_study_id