Prospective randomized controlled trial of oral sodium phosphate and polyethylene glycol lavage in bowel preparation for colonoscopy

UMIN ID: UMIN000001303

Registered date:07/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients scheduled for colonoscopy
• Date of first enrollment: 2008/08/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Niflec(polyethylene glycol lavage) group 1) 10ml Laxoberon Solution is administered orally at bedtime 2) Patients are instructed to drink only clear liquids after dinner 3) At our endscopy unit, patient should drink 2L polyethylene glycol lavage (Niflec) at the speed of about 200ml for every ten minutes from beginning time (10:00 a.m.)
Visiclear(oral phosphate tablets) group 1) 10ml Laxoberon Solution is administered orally at bedtime 2) Patients are instructed to drink only clear liquids after dinner 3) At our endoscopy unit, patient should take 40 sodium phosphate tablets (Visiclear tablets) in divided doses (take as 5 tablets every 15 minutes with 200mL of clear liquids [water or tea]) from beginning time (10:00 a.m.)

Outcome(s)

• Primary Outcome: To evaluate detection rates of polyps smaller than 5mm
• Secondary Outcome: To evaluate detection rates of all prominent lesions and diverticula To evaluate blood pressure and pulse rates of patients before and after colonoscopy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: The following proceduresis excluded from the criteria 1) Patients with uncontrolled congestive heart failure, unstable angina, untreated cardiac arrhythmia, prolong QT interval, myocardial infarction, percutaneous transluminal coronary angioplasty or previous coronary artery bypass graft surgery, basic heart disease (valvular disease, cardiomyopathy, and arrhythmia, etc.) 2) Patients with the presence of ascites 3) Patients with acute bowel obstruction or pseudo-obstruction of the bowel 4) Patients with toxic megacolon 5) Patients with biopsy-proven acute phosphate nephropathy 6) Patients who is known allergy or hypersensitivity to NaP salts or PEG 7) Patients with renal insufficiency (creatinine>2.0mg/dL or BUN>25mg/dL) 8) Patients with a history of convulsive attack or Patients at higher risk of convulsive attack 9) Patients with severe chronic constipation 10) Patients with clinical symptoms caused by narrowing of colon lumen or diverticulosis of colon 11) Patients who need emergency colonoscopy 12) Patients with inflammatory bowel disease 13) Pregnant females and lactating women 14) Patients who needs endoscopic therapy (EMR, polypectomy, etc.) 15) Patients who have past history of abdominal surgery other than appendectomy 16) Patients whom examination the responsible(contributory) doctor evaluate inappropriate as study subjects

Related Information

• Primary Sponsor: Department of Gastroenterology, The University of Tokyo Hospital
• Source(s) of Monetary Support: Department of Gastroenterology, The University of Tokyo Hospital