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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:

Efficacy

Efficacy

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

Page last updated: August 23, 2015

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