UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001303
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001532

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.