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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Performing a complete and successful full colonoscopy.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: 4-L split-dose polyethylene glycol and Bisacodyl + Docusate sodium. (Drug)
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.
Intervention: 2-L split-dose polyethylene glycol plus Oral Simethicone regimen . (Drug)
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.
Intervention: 2-L split-dose polyethylene glycol regimen (Drug)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Tanta University