drugset / Trial / NCT07328880

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

Recruiting 450 enrolled Tanta University
RandomizedParallel-groupTriple-blindDiagnostic

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Bisacodyl Small molecule 10 mg Oral
Subject Docusate Sodium Unknown 100 mg Oral
Comparator Simethicone Other / unclassified Oral
Subject polyethylene glycol Other / unclassified 2000 ml Oral
Subject polyethylene glycol Other / unclassified 4000 ml Oral

Indications

No indication recorded.