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RECRUITING
NCT07328880
NA

4-L Split-dose Polyethylene Glycol and Bisacodyl and Docusate Sodium Regimen Versus 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen for Bowel Preparation Before Colonoscopy

Sponsor: Tanta University

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled trial is to compare the safety, compliance, and efficacy of different bowel preparation methods prior to colonoscopy. Researchers will compare 4-L split-dose polyethylene glycol and the bisacodyl + docusate sodium regimen versus 2-L split-dose polyethylene glycol plus oral simethicone regimen versus the conventional method for bowel preparation before colonoscopy. Participants will undergo history-taking, clinical examination, laboratory investigations, and colonoscopy. Patients will be randomly assigned to receive 4-L split-dose polyethylene glycol and bisacodyl + docusate sodium, a 2-L split-dose polyethylene glycol regimen plus oral simethicone, or 2-L split-dose polyethylene glycol alone as a control. Colonoscopy will be done 24 hrs after the start of medication. Researchers will assess the quality of the bowel preparation using the Aronchick bowel preparation scale. Researchers will also assess the number of adverse events and ask the patients about the ease of bowel preparation administration, tolerability of preparation regimen, and willingness to take the same agent again for a repeat colonoscopy in the future.

Official title: Comparative Study Between Using a 4-L Split-dose Polyethylene Glycol and Bisacodyl + Docusate Sodium Regimen Versus a 2-L Split-dose Polyethylene Glycol Plus Oral Simethicone Regimen Versus Conventional Method for Bowel Preparation Before Colonoscopy

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-04-01

Completion Date

2026-04-26

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

4-L split-dose polyethylene glycol and Bisacodyl + Docusate sodium.

Patients who were randomized to receive PEG were instructed to mix four sachets of PEG (Moviprep) in 4 liters of water and drink it over a period of 8 hours starting at 09:00 a.m. and Biscodyl 10 mg + Docusate sodium 100 mg (Minalax) 8 tablets.

DRUG

2-L split-dose polyethylene glycol plus Oral Simethicone regimen .

Patients who are randomized to receive PEG with simethicone are instructed to mix two sachets of PEG (Moviprep) in 2 liters of water and drink it over a period of 4 hours starting at 09:00 a.m. with simethicone (Flatidyl) 4 tablets.

DRUG

2-L split-dose polyethylene glycol regimen

Patients who are randomized to receive PEG with simethicone instructed to mix two sachet of PEG (moviprep) in 2 liters of water and drink it over a period of 4 hours starting at 09:00 a.m.

Locations (1)

Tanta University Hospitals

Tanta, Gharbyea, Egypt