Clinical trial NCT01481714: Efficacy and Safety of Split-dose Citrafleet Administered From 2 to 6 Hours Before Morning Colonoscopies
Official title: Phase IV, Prospective, Randomized Study Comparing Preparation the Day Before and Split-dose Regimen With Sodium Picosulphate/Magnesium Citrate for Morning Colonoscopies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Cleansing
Colonoscopy
Keywords: Sodium picosulphate
Split-dose
Bowel cleansing
colonoscopy
Degree of bowel cleansing during colonoscopy
Lead sponsor: Infante, Javier Molina, M.D.
Sponsor class: INDIV
First posted: 2011-11-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of bowel cleansing (Boston Scale 0-3) in each anatomical segment of the colon
timeFrame: 4 months
Secondary outcomes:
measure: Rate of aspiration bronchopneumonia
timeFrame: 4 months
measure: Adenoma detection rate
timeFrame: 4 months
Other outcomes:
Locations:
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
Study officials:
affiliation: Hospital San Pedro de Alcantara, Caceres, Spain
name: Javier Molina-Infante, MD
role: PRINCIPAL_INVESTIGATOR
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