UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035456 |
|---|---|
| Receipt number | R000040298 |
| Scientific Title | Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin. |
| Date of disclosure of the study information | 2019/01/06 |
| Last modified on | 2019/07/22 15:13:52 |
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Basic information
Public title
Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Acronym
Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Scientific Title
Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Scientific Title:Acronym
Prospective, Randomized controlled trial on efficacy of extended cold snare polypectomy specimen about pathological horizontal margin.
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of lesions resected by cold snare polypectomy and pasted on paper.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evalution of pathological horizontal margin of specimens resected with cold snare polypectomy
Key secondary outcomes
Size of specimens
location of the lesion
operater
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
specimens resected by cold snare polypectomy and pasted on a paper
Interventions/Control_2
specimens resected by cold snare polypectomy without paste
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients had adenoma resected by cold snare polypectomy
Key exclusion criteria
Adenoma resected piecemeal
Pathological diagnosis is not adenoma
After colon surgery.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yoshizaki |
Organization
Saiseikai nakatsu Hospital
Division name
Gastroenterology
Zip code
530-0012
Address
2-10-39, Shibata, Osaka Shi Kita Ku, Osaka Fu, 530-0012, Japan
TEL
06-6372-0333
yoshizak@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ikeda |
Organization
Saiseikai nakatsu Hospital
Division name
Department of Clinical Laboratory
Zip code
530-0012
Address
2-10-39, Shibata, Osaka Shi Kita Ku, Osaka Fu, 530-0012, Japan
TEL
06-6372-0333
Homepage URL
tikeda-nakatsu@umin.ac.jp
Sponsor or person
Institute
Saiseikai nakatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Saiseikai nakatsu Hospital
Address
2-10-39, Shibata, Osaka Shi Kita Ku, Osaka Fu, 530-0012, Japan
Tel
06-6372-0333
tikeda-nakatsu@umin.ac.jp
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
| 2019 | Year | 01 | Month | 06 | 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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040298
