About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
4-L split-dose polyethylene glycol and Bisacodyl + Docusate sodium.
DrugPatients 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 .
DrugPatients 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
DrugPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Bowel preparation side effects
Any adverse events (like nausea, vomiting, dizziness, pain abdomen, bloating and anal irritation) will be recorded.
Ease of bowel preparation administration
Patients were asked to rate the ease of administration and taste as easy/tolerable/difficult/intolerable.
Tolerability assessment
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.
Sponsors and contacts
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