UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001303 |
|---|---|
| Receipt number | R000001532 |
| Scientific Title | Prospective randomized controlled trial of oral sodium phosphate and polyethylene glycol lavage in bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2008/08/07 |
| Last modified on | 2010/10/11 12:02:03 |
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Basic information
Public title
Prospective randomized controlled trial of oral sodium phosphate and polyethylene glycol lavage in bowel preparation for colonoscopy
Acronym
VisiN study
Scientific Title
Prospective randomized controlled trial of oral sodium phosphate and polyethylene glycol lavage in bowel preparation for colonoscopy
Scientific Title:Acronym
VisiN study
Region
| Japan |
Condition
Condition
Patients scheduled for colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of oral phosphate tablets and polyethylene glycol lavage in bowel preparation for colonoscopy by
comparison of lesion detection rates
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate detection rates of polyps smaller than 5mm
Key secondary outcomes
To evaluate detection rates of all prominent lesions and diverticula
To evaluate blood pressure and pulse rates of patients before and after
colonoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
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.)
Interventions/Control_2
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.)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who fills everything the
following
1) Patients scheduled for colonoscopy in our hospital
2) Age of patients is from 20 to 75 years old
3) Patients who were able to
provide written informed consent for
participation in this study
4) Outpatient and in-patient
Key exclusion 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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamaji |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
03-3815-5411(33070)
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2008 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 07 | Day |
Last modified on
| 2010 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001532
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