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Recruiting Not applicable

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 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2026-01-09

Condition(s) studied

Colonoscopy Preparation

Investigational drug(s) / intervention(s)

4-L split-dose polyethylene glycol and Bisacodyl + Docusate sodium.2-L split-dose polyethylene glycol plus Oral Simethicone regimen .2-L split-dose polyethylene glycol regimen

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.

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing colonoscopy as a day-care procedure for various indications (lower GI bleeding, colorectal cancer screening, altered bowel habits, etc.) * Patients of either sex aged \>18 years and \<70 years. * Patients willing to give written informed consent. Exclusion Criteria: * Presence of Renal failure, cirrhosis, ascites, CCF, bleeding disorders, seizure disorder, gastrointestinal obstruction, or perforation. * History of serious adverse events to other electrolyte-based colonic lavages. * Female patients who are pregnant or lactating or considering pregnancy. * Allergy.

Primary outcome measure(s)

  • Performing a complete and successful full colonoscopy. — through study completion, an average of 1 year
    Bowel preparation administration, whether completed or not, and the reason for it will be recorded. Assessment of the quality of the bowel preparation using the Aronchick bowel preparation scale.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Hospitals Tanta Gharbyea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07328880 on ClinicalTrials.gov ↗ ← All trials in Egypt