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

NCT ID: NCT02040285

Last Updated: 2014-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-07-31

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.

Conditions

Gastrointestinal Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Free laxative CTC

Group Type: ACTIVE_COMPARATOR

Iopamidol

Intervention Type: DRUG

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

Low-dose laxative bowel preparation for CTC

Group Type: EXPERIMENTAL

Bisacodyl & PEG-CS

Intervention Type: DRUG

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

Interventions

Bisacodyl & 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

Intervention Type: DRUG

Iopamidol

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

Intervention Type: DRUG

Other Intervention Names

Lovoldyl (Bisacodyl); Lovolesse (PEG-CS); Gastromiro (Iopamidol); Plasil (Metoclopramide mono chlorohydrate monohydrate); Gastromiro (Iopamidol)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Policlinico Umberto I

OTHER

Sponsor Role: lead

Responsible Party

Andrea Laghi

Prof., MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico Umberto I

Roma, , Italy

Countries

Italy

Other Identifiers

CTC-Prep 1

Identifier Type: -

Identifier Source: org_study_id