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
| NCT ID | NCT07328880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Colonoscopy Preparation |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Nabila A Elgazzar, MD
STUDY DIRECTOR
Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University
Frequently Asked Questions
Who can join the NCT07328880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Colonoscopy Preparation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07328880 currently recruiting?
Yes, NCT07328880 is actively recruiting participants. Contact the research team at rania.elkafoury@med.tanta.edu.eg for enrollment information.
Where is the NCT07328880 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT07328880 clinical trial?
NCT07328880 is sponsored by Tanta University. The principal investigator is Nabila A Elgazzar, MD at Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University. The trial plans to enroll 450 participants.