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

Phase 4

Completed

• Conditions: Gastrointestinal Complication
• Interventions: Drug: Bisacodyl & PEG-CS; Drug: Iopamidol

• Registration Number: NCT02040285
• Lead Sponsor: Azienda Policlinico Umberto I

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-17
• Last Update Submitted: 2014-01-17
• Study First Posted: 2014-01-20
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose laxative bowel preparation for CTC	Bisacodyl & PEG-CS	-
Free laxative CTC	Iopamidol	-

Primary Outcome Measures

Name	Time	Method
Efficacy	20 min	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).

Secondary Outcome Measures

Name	Time	Method
Safety	2 days (the day before and the day of the exam)	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.
Efficacy	20 min	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)
Acceptability	2 days (the day before and the day of the exam)	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.

Trial Locations

Locations (1)

Policlinico Umberto I; 🇮🇹 Roma, Italy