Colonoscopy Preparation
Conditions
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.
Interventions
DRUG4-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.
DRUG2-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.
DRUG2-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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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. * Allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performing a complete and successful full colonoscopy. | 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
| Measure | Time frame | Description |
|---|---|---|
| Bowel preparation side effects | through study completion, an average of 1 year | Any adverse events (like nausea, vomiting, dizziness, pain abdomen, bloating and anal irritation) will be recorded. |
| Ease of bowel preparation administration | through study completion, an average of 1 year | Patients were asked to rate the ease of administration and taste as easy/tolerable/difficult/intolerable. |
| Tolerability assessment | 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. |
Countries
Egypt
Contacts
Primary ContactRania M Elkafoury, MD
Backup ContactNabila A Elgazzar, MD
Outcome results
None listed