MedTrace Logo

Efficacy and Safety of Split-dose Citrafleet Administered From 2 to 6 Hours Before Morning Colonoscopies

NCT01481714 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-11-29

No results posted yet for this study

Summary

An excellent bowel cleansing is mandatory to increase the diagnostic accuracy of colonoscopy. Failure to adequately cleanse the bowel for colonoscopy can lead to missed lesions, prolonged procedure duration and repeated procedures at earlier intervals. Emerging solid evidence is pointing out the need of switching from preparation the day before to regimens in which half or even more of the preparation is administered the same day of the procedure, which have extensively demonstrated to provide a significantly better cleansing, being well tolerated. Preparation can be fully administered the same day for afternoon procedures, whereas split-dose regimens fit better with morning colonoscopies. However, the ideal regimen for early morning colonoscopies is still to be elucidated. The second part of the preparation for these patients is usually recommended to be taken during sleeping time (2-3 am) on the belief that intake of fluids should be completely halted at least four hours prior to the colonoscopy procedure Sodium picosulphate is a unique orange-flavoured cleansing agent dosed as two powder sachets. Mayor advantages in comparison with current alternatives are relatively small volumes (each sachet is mixed with only 150-250 mL of water) and a more pleasant taste. It provides similar bowel cleansing than sodium phosphate and polyethylene glycol solutions administered the day before. Nonetheless, focus on split-dose regimens has been set on several polyethylene glycol (either high-volume or low-volume) regimens, but no data are available for split-dose sodium-picosulphate regarding colonoscopy in adults.

The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate low-volume split-dose regimen, in which the second-half of the preparation and fluids intake are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning colonoscopies, comparing this split-dose regimen with standard cleansing the day before with sodium picosulphate/magnesium citrate.

Conditions

  • Bowel Cleansing
  • Colonoscopy

Interventions

DRUG

Sodium picosulphate, magnesium oxid and citric acid

* A sachet mixed with 250 mL of water at 18:00 pm * A sachet mixed with 250 mL of water at 21:00 pm * A minimum of 4 litres of fluid were recommended throughout the preparation

DRUG

Sodium picosulphate/magnesium oxide and citric acid

The day before the procedure: \- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids The day of the procedure: * A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am. * A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am.

Sponsors & Collaborators

  • Infante, Javier Molina, M.D.

    lead INDIV

Principal Investigators

  • Javier Molina-Infante, MD · Hospital San Pedro de Alcantara, Caceres, Spain

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481714 on ClinicalTrials.gov