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The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient tolerability and acceptance.
Computed Tomography Colonography (CTC) is a valid alternative to colonoscopy in the detection of cancer, polyps and other colon lesions.
High volume cathartic preparations, low volume cathartic solutions with oral tagging agent and tagging agent only are the procedures available for CTC.
High volume preparations are a considerable burden for patients. Low volume cathartic solutions are more accepted by the patients, reduce the amount of tagging agent and the waiting time to the exam. Tagging agent only preparations represent a risk if they are taken without medical supervision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free laxative CTC | Active Comparator |
| |
| Low-dose laxative bowel preparation for CTC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisacodyl & PEG-CS | Drug | the day before the CTC:
the day of the exam:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Tagging. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of residuals to 3= minor than 25% of residuals). | 20 min |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Residual fluid evaluation. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 1= minor than 25% of the ap axis to 4= greater than 75% of the ap axis). | 20 minutes |
| Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Umberto I | Roma | Italy |
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| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
|
| Iopamidol | Drug | the day before CTC:
|
|
|
Bowel distension. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of the maximal distension to 3= minor than 25% of the maximal distension) |
| 20 min |
| Safety | Recording of all Adverse Events (AEs) occurring during the 2 days of treatment | 2 days (the day before and the day of CTC) |
| Safety | Tolerability. Recording of gastrointestinal (GI) symptoms occurring during the 2 days of treatment. Intensity of GI symptoms will be evaluated by a Visual Analgic Scale (VAS) ranging from 0=no symptoms to 10=severe, as much as possible. | 2 days (the day before and the day of the exam) |
| Acceptability | Evaluation of the patient discomfort related to bowel preparation. A 4 point scale is used: 1=none; 2=mild distress; 3=moderate distress; 4=severe distress. | 2 days (the day before and the day of the exam) |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |