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

Gastrointestinal Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040285
• Other study ID #: CTC-Prep 1
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2014
• Last updated: January 17, 2014
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: January 2014
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Complication

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Safety	Recording of all Adverse Events (AEs) occurring during the 2 days of treatment	2 days (the day before and the day of CTC)	Yes
Secondary	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)	Yes
Secondary	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)	No