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

Azienda Policlinico Umberto I

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Complication

Treatments: Drug: Bisacodyl & PEG-CS; Drug: Iopamidol

Study type: Interventional

Funder types: Other

Identifiers

NCT02040285

CTC-Prep 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Free laxative CTC

Active Comparator group

Treatment:

Drug: Iopamidol

Low-dose laxative bowel preparation for CTC

Experimental group

Treatment:

Drug: Bisacodyl & PEG-CS