Gastrointestinal Complication
Conditions
Keywords
CT colonography
Brief summary
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.
Detailed description
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.
Interventions
DRUGBisacodyl & PEG-CS
the day before the CTC: * low fiber diet * at 15.00: 2 tablets of bisacodyl (5 mg) * at 17.00: 1 litre of PEG-CS * liquid diet the day of the exam: * at home: 2 tablets of bisacodyl (5 mg) * at the Hospital (3 hours after tablets intake): 90 ml of Iopamidol in 500 ml of water * at the Hospital (5 minutes after Iopamidol intake): 10 mg of Metoclopramide mono chlorohydrate monohydrate im
DRUGIopamidol
the day before CTC: * low fiber diet * at 15.00: 90 ml of Iopamidol in 250 ml of water * at 17.00: 90 ml of Iopamidol in 250 ml of water * at 20.00: start liquid diet
Sponsors
Azienda Policlinico Umberto I
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 CTC * 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, ileo, major colonic surgery * History of anaphylaxis to Iopamidol or allergic reactions to drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 20 min | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 20 minutes | 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). |
| Safety | 2 days (the day before and the day of CTC) | Recording of all Adverse Events (AEs) occurring during the 2 days of treatment |
| Acceptability | 2 days (the day before and the day of the exam) | 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. |
Countries
Italy
Outcome results
None listed