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

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infante, Javier Molina, M.D.
• Treatments: Citric Acid; Magnesium Oxide; Picosulfate sodium; Sodium Citrate

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