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

November 28, 2011 updated by: Infante, Javier Molina, M.D.

Phase IV, Prospective, Randomized Study Comparing Preparation the Day Before and Split-dose Regimen With Sodium Picosulphate/Magnesium Citrate for Morning Colonoscopies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Justification of the study:

Several split-dose bowel cleansing regimens have raised over the last decade aiming to substitute standard preparation the day before. These split-dose regimens (based on sodium phosphate and polyethylene glycol solutions) have demonstrated better cleansing scores, so it is probably more important the time that preparation is given rather than the type of solution. However, the time to administer the second half of the solution in split-dose regimens for morning colonoscopies remains controversial. A major concern of split-dose regimens is the risk of aspiration pneumonia during sedation if liquids have been administered quite close to the procedure. As such, the second part of the preparation is usually given early in the morning (2-3 am) in order to have a safety-period of at least four hours prior to the colonoscopy. However, this is quite disturbing for patients and may hamper the adherence to further colonoscopies. Furthermore, On the other hand, no study addressing the role of split-dose Citrafleet has been published to date

Therefore it is necessary to make a controlled clinical trial to directly compare "the day before" and " split-dose" regimens with Citrafleet for morning colonoscopies. In order to maximize the efficacy of the split-dose regimens, the time period between fluids intake and the colonoscopy will be shortened up up to 2 hours for morning colonoscopies scheduled from 9 to 11 am and up to 3 hours for that scheduled after 11 am. The results of this study will conclude whether there is still room for improvement in bowel cleansing for morning colonoscopies, using more palatable low-volume solutions without interrupting sleep time.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Caceres, Spain, 10003
        • Recruiting
        • Hospital San Pedro de Alcántara
        • Contact:
        • Principal Investigator:
          • Javier Molina-Infante
        • Sub-Investigator:
          • Gema Vinagre-Rodriguez
        • Sub-Investigator:
          • Moises Hernandez-Alonso
        • Sub-Investigator:
          • Carmen Dueñas-Sadornil
        • Sub-Investigator:
          • Miguel Fernandez-Bermejo
        • Sub-Investigator:
          • Jose M Mateos-Rodriguez
        • Sub-Investigator:
          • Elisa Martin-Noguerol
        • Sub-Investigator:
          • Jesus M Gonzalez-Santiago
        • Sub-Investigator:
          • Carmen Martinez-Alcala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients undergoing routine elective colonoscopy

Exclusion Criteria:

  • pregnant or lactating women
  • age less than 18 years
  • significant gastroparesis or gastric outlet obstruction or ileus
  • known or suspected bowel obstruction or perforation
  • phenylketonuria or glucose-6-phosphate dehydrogenase deficiency
  • severe chronic renal failure (creatinine clearance < 30 mL/minute)
  • severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
  • dehydration
  • severe acute inflammatory disease
  • compromised swallowing reflex or mental status
  • uncontrolled hypertension (systolic blood pressure > 170 mm Hg ad/or diastolic blood pressure > 100 mm Hg)
  • toxic colitis
  • megacolon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium Picosulphate preparation the day before

Preparation the day before of the procedure using sodium picosulphate:

  • 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 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
Experimental: Split-dose sodium picosulphate preparation

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of bowel cleansing (Boston Scale 0-3) in each anatomical segment of the colon
Time Frame: 4 months
Boston Scale: 3: excellent; 2: good ; 1: fair; 0: poor. Anatomical segments of the colon: rectum, sigmoid colon, descending colon, transverse colon, ascending colon and cecum
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of aspiration bronchopneumonia
Time Frame: 4 months
4 months
Adenoma detection rate
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infante, Javier Molina, M.D.

Investigators

  • Principal Investigator: Javier Molina-Infante, MD, Hospital San Pedro de Alcantara, Caceres, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CITRA-SPLIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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