NCT02040285

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2014-01-20
• Last updated: 2014-01-20

Locations

1 site across 1 country: Italy