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

NCT ID: NCT07328880

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-04-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

2-L split-dose polyethylene glycol regimen

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rania Mamdouh Elkafoury

Lecturer of Tropical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nabila A Elgazzar, MD

Role: STUDY_DIRECTOR

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

Locations

Tanta University Hospitals

Tanta, Gharbyea, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rania M Elkafoury, MD

Role: CONTACT

rania.elkafoury@med.tanta.edu.eg

+201004672358

Nabila A Elgazzar, MD

Role: CONTACT

nabilaelgazzar@med.tanta.edu.eg

00201288585733

Facility Contacts

Dina H Ziada, MD

Role: primary

dina.ziada@med.tanta.edu.eg

00201117109990

Role: backup

dr_ranon3000@yahoo.com

Other Identifiers

36264PR1193/4/25

Identifier Type: -

Identifier Source: org_study_id