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

NCT02040285 | Completed Phase 4

• 1 other identifier: CTC-Prep 1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Complication

Keywords

CT colonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Efficacy

  20 minutes

• Efficacy

  20 min

• Safety

  2 days (the day before and the day of CTC)

• Safety

  2 days (the day before and the day of the exam)

• Acceptability

  2 days (the day before and the day of the exam)

Study Arms (2)

Free laxative CTC

ACTIVE COMPARATOR

Drug: Iopamidol

Low-dose laxative bowel preparation for CTC

EXPERIMENTAL

Drug: Bisacodyl & PEG-CS

Interventions

Bisacodyl & PEG-CS 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

Also known as: Lovoldyl (Bisacodyl), Lovolesse (PEG-CS), Gastromiro (Iopamidol), Plasil (Metoclopramide mono chlorohydrate monohydrate)

Low-dose laxative bowel preparation for CTC

Iopamidol 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

Also known as: Gastromiro (Iopamidol)

Free laxative CTC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-patients undergoing a CTC
• Patient written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead

Study Sites (1)

Policlinico Umberto I

Roma, Italy

Location

MeSH Terms

Interventions

Bisacodyl; Iopamidol

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 20, 2014
• Study Start: February 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

IT (1)