Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC). Comparison vs Laxative Free CTC.

Conditions
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Gastrointestinal Complication

Intervention / Treatment
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* Drug: Bisacodyl & PEG-CS
* Drug: Iopamidol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free laxative CTC<br> | Drug: Iopamidol<br>* 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<br>* Other names: Gastromiro (Iopamidol);|
| Experimental: Low-dose laxative bowel preparation for CTC<br> | Drug: Bisacodyl & PEG-CS<br>* 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<br>* Other names: Plasil (Metoclopramide mono chlorohydrate monohydrate);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT colonography