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NCT Number: 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

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.

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Key information

Conditions

Colonoscopy Preparation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Amal M Dwidar, MD

SUB_INVESTIGATOR

Assem A Elfert, MD, PHD

PRINCIPAL_INVESTIGATOR

Dina H Ziada, MD

CONTACT

[email protected]

00201117109990

Eslam S Ismaiel, MD

SUB_INVESTIGATOR

Nabila A Elgazzar, MD

PRINCIPAL_INVESTIGATOR

Rania M Elkafoury, MD

SUB_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 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.

Primary outcomes

  1. Performing a complete and successful full colonoscopy.

    Time frame: 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.

Secondary outcomes

  1. Bowel preparation side effects

    Time frame: through study completion, an average of 1 year

    Any adverse events (like nausea, vomiting, dizziness, pain abdomen, bloating and anal irritation) will be recorded.

  2. Ease of bowel preparation administration

    Time frame: through study completion, an average of 1 year

    Patients were asked to rate the ease of administration and taste as easy/tolerable/difficult/intolerable.

  3. Tolerability assessment

    Time frame: through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nabila A Elgazzar, MD

CONTACT

[email protected]

00201288585733

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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