Colonoscopy
Conditions
Brief summary
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
Interventions
DRUG2L PEG-CS plus bisacodyl
Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)
DRUG2L PEG-ASC
Patients will asked to take PEG-ASC according to labeling instructions
Sponsors
Promefarm S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 * Hypersensitivity to any of the ingredients * History of anaphylaxis to drugs or allergic reactions in general * Known or suspected gastrointestinal obstruction or perforation * Toxic megacolon; major colonic resection * Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study * Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency * Unwillingness to co-operate and to comply with the requirements of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the quality of bowel preparation by BBPS | 20 minutes | BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mucosal visibility between the two groups | 20 minutes | Three point rating scale(0-2). |
| Number of patients with adverse events | 24 hours | Patient questioning. |
| Difference in tolerability between the two groups | 24 hours | Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation. |
| Difference in patients acceptability between the two groups | 24 hours | Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation. |
| Difference in patients compliance between the two groups | 24 hours | Difference in the percentage of patients who took at least 75% of bowel preparation. |
Countries
Italy
Outcome results
None listed