UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035106 |
|---|---|
| Receipt number | R000039227 |
| Scientific Title | Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers |
| Date of disclosure of the study information | 2018/12/02 |
| Last modified on | 2021/06/26 20:14:34 |
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Basic information
Public title
Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers
Acronym
The efficacy of reduced port surgery for colorectal cancers
Scientific Title
Prospective cohort study and construction of a scoring system related to reduced port surgery for colorectal cancers
Scientific Title:Acronym
The efficacy of reduced port surgery for colorectal cancers
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of reduced port surgery (RPS) for colorectal cancers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To prove the safety of RPS for colorectal cancers
Key secondary outcomes
To establish the scoring sytem of difficulty
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
colorectal cancer patients
Key exclusion criteria
Nil
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Umemura |
Organization
Morioka Municipal Hospital
Division name
Department of Surgery
Zip code
020-0866
Address
5-15-1 Motomiya, Morioka
TEL
0196350101
aumemura@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Umemura |
Organization
Morioka Municipal Hospital
Division name
Department of Surgery
Zip code
020-0866
Address
5-15-1 Motomiya, Morioka
TEL
0196350101
Homepage URL
aumemura@iwate-med.ac.jp
Sponsor or person
Institute
Morioka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Morioka Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morioka Municipal Hospital
Address
5-15-1 Motomoiya, Morioka city
Tel
0196350101
auau001@hotmail.com
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
盛岡市立病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1015958421003110
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1015958421003110
Number of participants that the trial has enrolled
112
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 | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Paper accepted
Management information
Registered date
| 2018 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039227
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
