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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022967-37 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG 4 litres split | Active Comparator | Polyethylene glycol with electrolytes (PEG) |
|
| Bisacodyl plus PEG-CS | Experimental | Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisacodyl plus PEG-CS | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Evaluation of the quality of bowel preparation according to the Ottawa Scale | 20 min |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Evaluation of the mucosal visibility according to a 3 point scale (0-2) | 20 min |
| Efficacy | Adenoma detection rate | 20 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiano Crosta, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
| PEG 4 litres split | Drug |
|
|
|
| Safety | Recording of all adverse events occurred during the study by patient questioning | 24 hours |
| Tolerability | rate of patients in the two groups who developed GI symptoms related to bowel preparation | 24 hours |
| Acceptability | willingness to repeat the preparation | 24 hours |
| Compliance | rate of patient with intake of at least 75% of bowel preparation | 24 hours |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |