Colonoscopy
Conditions
Brief summary
The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.
Detailed description
Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.
Interventions
DRUGBisacodyl plus PEG-CS
* the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime * the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam
DRUGPEG 4 litres split
* the day before colonoscopy: 2 litres of PEG * the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Out-patients undergoing a complete colonoscopy * Patient written informed consent
Exclusion criteria
* Pregnant or lactating women or at a risk of becoming pregnant * Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 20 min | Evaluation of the quality of bowel preparation according to the Ottawa Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 20 min | Evaluation of the mucosal visibility according to a 3 point scale (0-2) |
| Safety | 24 hours | Recording of all adverse events occurred during the study by patient questioning |
| Tolerability | 24 hours | rate of patients in the two groups who developed GI symptoms related to bowel preparation |
| Acceptability | 24 hours | willingness to repeat the preparation |
| Compliance | 24 hours | rate of patient with intake of at least 75% of bowel preparation |
Countries
Italy
Outcome results
None listed