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JAPANESE
国立保健医療科学院
UMIN ID: UMIN000020904

Registered date:08/02/2016

1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedColon diseases (Patients undergoing routine total colonoscopy)
Date of first enrollment2014/10/31
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)On the day before colonoscopy: 48mg of sennoside once at bedtime. On the day of colonoscopy: 1.2L of polyethylene glycol + ascorbic acid (Moviprep; Ajinomoto Ltd, Tokyo, Japan; composed of 200g of macrogol 4000, electrolytes and 9.400g ascorbic acid) diluted into 2.0L of plain water and at least 0.6L of additional clear fluid. On the day before colonoscopy: 48mg of sennoside once at bedtime. On the day of colonoscopy: 2.0L of polyethylene glycol-electrolyte (Nifrec; Ajinomoto Ltd, Tokyo, Japan; composed of macrogol 4000 and electrolytes) diluted into 2.0L of plain water.

Outcome(s)

Primary OutcomeDegree of colon cleansing assessed by Boston Bowel Preparation Scale (BBPS) and an original scoring system.
Secondary OutcomeVolume of fluid intake, required time to bowel preparation, result of questionnaire on acceptability and evaluation for safety.

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. Patients who have known or suspected bowel obstruction or ileus. 2. Patients who have known or suspected perforation. 3. Patients who have significant gastroparesis or gastric outlet obstruction. 4. Patients with severe chronic renal failure (creatinine clearance <30 mL/minute) and severe congestive heart failure (New York Heart Association [NYHA] class III or IV). 5. Patients with sustained tachyarrhythmia. 6. Patients with uncontrolled hypertension (systolic blood pressure >170 mm Hg, diastolic blood pressure >100mmHg). 7. Patients with toxic colitis or megacolon. 8. Pregnant or lactating women.

Related Information

Contact

public contact
Name Hiroyuki Tamaki
Address 4-1-3, Ban-cho, Takamatsu, Kagawa Japan 7600017
Telephone 087-837-7101
E-mail h-tama@gc4.so-net.ne.jp
Affiliation Takamatsu Redcross Hospital Gastroenterology
scientific contact
Name Hiroyuki Tamaki
Address 4-1-3, Ban-cho, Takamatsu, Kagawa Japan
Telephone 087-831-7101
E-mail h-tama@gc4.so-net.ne.jp
Affiliation Takamatsu Redcross Hospital Gastroenterology