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Completed

NCT Number: NCT02040285

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

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Key information

Conditions

Gastrointestinal Complication

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Policlinico Umberto I

Roma, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Lovoldyl (Bisacodyl), Lovolesse (PEG-CS), Gastromiro (Iopamidol), Plasil (Metoclopramide mono chlorohydrate monohydrate)

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

Other names: Gastromiro (Iopamidol)

Primary outcomes

  1. Efficacy

    Time frame: 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 outcomes

  1. Efficacy

    Time frame: 20 minutes

    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).

  2. Efficacy

    Time frame: 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)

  3. Safety

    Time frame: 2 days (the day before and the day of CTC)

    Recording of all Adverse Events (AEs) occurring during the 2 days of treatment

  4. Safety

    Time frame: 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.

  5. Acceptability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Policlinico Umberto I

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2014
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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