Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)
Information source: Azienda Policlinico Umberto I
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastrointestinal Complication
Intervention: Bisacodyl & PEG-CS (Drug); Iopamidol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Azienda Policlinico Umberto I
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.
Clinical Details
Official title: Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC). Comparison vs Laxative Free CTC.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy
Secondary outcome: EfficacyEfficacy Safety Safety Acceptability
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Policlinico Umberto I, Roma, Italy
Additional Information
Starting date: February 2012
Last updated: January 17, 2014
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