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.

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Complication
• Intervention / Treatment: Drug: Iopamidol; Drug: Bisacodyl & PEG-CS

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Policlinico Umberto I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Free laxative CTC	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; Other Names: Gastromiro (Iopamidol)
Experimental: Low-dose laxative bowel preparation for CTC	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; Other Names: Lovoldyl (Bisacodyl); Lovolesse (PEG-CS); Gastromiro (Iopamidol); Plasil (Metoclopramide mono chlorohydrate monohydrate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Tagging. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of residuals to 3= minor than 25% of residuals).	20 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Residual fluid evaluation. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 1= minor than 25% of the ap axis to 4= greater than 75% of the ap axis).	20 minutes
Efficacy	Bowel distension. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of the maximal distension to 3= minor than 25% of the maximal distension)	20 min
Safety	Recording of all Adverse Events (AEs) occurring during the 2 days of treatment	2 days (the day before and the day of CTC)
Safety	Tolerability. Recording of gastrointestinal (GI) symptoms occurring during the 2 days of treatment. Intensity of GI symptoms will be evaluated by a Visual Analgic Scale (VAS) ranging from 0=no symptoms to 10=severe, as much as possible.	2 days (the day before and the day of the exam)
Acceptability	Evaluation of the patient discomfort related to bowel preparation. A 4 point scale is used: 1=none; 2=mild distress; 3=moderate distress; 4=severe distress.	2 days (the day before and the day of the exam)

Collaborators and Investigators

• Sponsor: Azienda Policlinico Umberto I

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: CT colonography
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Cathartics; Laxatives; Bisacodyl; Metoclopramide
• Other Study ID Numbers: CTC-Prep 1