A Phase 4 interventional study of Bisacodyl & PEG-CS and Iopamidol in Gastrointestinal Complication, sponsored by Azienda Policlinico Umberto I. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-01-20.
Sponsored by Azienda Policlinico Umberto I · Phase 4, Interventional, and Treatment
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.
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.
Azienda Policlinico Umberto I is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Iopamidol
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
Also known as: Lovoldyl (Bisacodyl), Lovolesse (PEG-CS), Gastromiro (Iopamidol), Plasil (Metoclopramide mono chlorohydrate monohydrate)
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)
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).
Time frame: 20 min
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).
Time frame: 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)
Time frame: 20 min
Safety
Recording of all Adverse Events (AEs) occurring during the 2 days of treatment
Time frame: 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.
Time frame: 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.
Time frame: 2 days (the day before and the day of the exam)
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Policlinico Umberto I