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

• 1 other identifier: 36264PR1193/4/25
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bowel preparation side effects

  through study completion, an average of 1 year

• Ease of bowel preparation administration

  through study completion, an average of 1 year

• Tolerability assessment

  through study completion, an average of 1 year

Study Arms (3)

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

EXPERIMENTAL

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.

2-L split-dose polyethylene glycol plus oral simethicone regimen .

ACTIVE COMPARATOR

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 .

2-L split-dose polyethylene glycol regimen (control).

ACTIVE COMPARATOR

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

Interventions

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

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.

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

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

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 plus oral simethicone regimen .

2-L split-dose polyethylene glycol regimen DRUG

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.

2-L split-dose polyethylene glycol regimen (control).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

RECRUITING

MeSH Terms

Interventions

Bisacodyl; Dioctyl Sulfosuccinic Acid

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids

Study Officials

• Nabila A Elgazzar, MD

  Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

  STUDY DIRECTOR

Central Study Contacts

Rania M Elkafoury, MD

CONTACT

+201004672358; rania.elkafoury@med.tanta.edu.eg

Nabila A Elgazzar, MD

CONTACT

00201288585733; nabilaelgazzar@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 26, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

EG (1)