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 |
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Health condition(s) or Problem(s) studied | Colon diseases (Patients undergoing routine total colonoscopy) |
Date of first enrollment | 2014/10/31 |
Target sample size | 300 |
Countries of recruitment | Japan |
Study type | Interventional |
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 Outcome | Degree of colon cleansing assessed by Boston Bowel Preparation Scale (BBPS) and an original scoring system. |
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Secondary Outcome | Volume of fluid intake, required time to bowel preparation, result of questionnaire on acceptability and evaluation for safety. |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. 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
Primary Sponsor | Takamatsu Red Cross Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | Takamatsu Red Cross Hospital |
Secondary ID(s) |
Contact
public contact | |
Name | Hiroyuki Tamaki |
Address | 4-1-3, Ban-cho, Takamatsu, Kagawa Japan 7600017 |
Telephone | 087-837-7101 |
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 |
h-tama@gc4.so-net.ne.jp | |
Affiliation | Takamatsu Redcross Hospital Gastroenterology |