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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy Preparation
• Intervention / Treatment: Drug: 4-L split-dose polyethylene glycol and Bisacodyl + Docusate sodium.; Drug: 2-L split-dose polyethylene glycol plus Oral Simethicone regimen .; Drug: 2-L split-dose polyethylene glycol regimen

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rania M Elkafoury, MD; Phone Number: +201004672358; Email: rania.elkafoury@med.tanta.edu.eg
• Study Contact Backup: Name: Nabila A Elgazzar, MD; Phone Number: 00201288585733; Email: nabilaelgazzar@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbyea
    • Tanta, Gharbyea, Egypt, 31516
      • Recruiting
      • Tanta University Hospitals
      • Sub-Investigator: Rania M Elkafoury, MD
      • Contact: Dina H Ziada, MD; Phone Number: 00201117109990; Email: dina.ziada@med.tanta.edu.eg
      • Contact: Email: dr_ranon3000@yahoo.com
      • Principal Investigator: Nabila A Elgazzar, MD
      • Sub-Investigator: Eslam S Ismaiel, MD
      • Sub-Investigator: Amal M Dwidar, MD
      • Principal Investigator: Assem A Elfert, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-L split-dose polyethylene glycol and Bisacodyl + docusate sodium.; 150 patients will be randomized to receive PEG and 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: 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.
Active Comparator: 2-L split-dose polyethylene glycol plus oral simethicone regimen .; 150 patients will be randomized to receive PEG with simethicone and 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 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.
Active Comparator: 2-L split-dose polyethylene glycol regimen (control).; 150 patients will be randomized to receive PEG with simethicone and 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performing a complete and successful full colonoscopy.	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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation side effects	Any adverse events (like nausea, vomiting, dizziness, pain abdomen, bloating and anal irritation) will be recorded.	through study completion, an average of 1 year
Ease of bowel preparation administration	Patients were asked to rate the ease of administration and taste as easy/tolerable/difficult/intolerable.	through study completion, an average of 1 year
Tolerability assessment	the tolerability is assessed based on whether the patient would take the preparation again in case repeat colonoscopy is required and rate the product as excellent/good/satisfactory/bad.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Nabila A Elgazzar, MD, Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 26, 2026

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Dicarboxylic Acids; Cresols; Succinates; Bisacodyl; Dioctyl Sulfosuccinic Acid
• Other Study ID Numbers: 36264PR1193/4/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No