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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

NCT07328880 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Colonoscopy Preparation

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Nabila A Elgazzar, MD · Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2026-04-26

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07328880 on ClinicalTrials.gov