UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016452 |
|---|---|
| Receipt number | R000018815 |
| Scientific Title | The research for laparoscopic navigation surgery by specific light band in colorectal operation. |
| Date of disclosure of the study information | 2015/02/06 |
| Last modified on | 2017/02/06 22:14:32 |
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Basic information
Public title
The research for laparoscopic navigation surgery by specific light band in colorectal operation.
Acronym
The resarch for laparoscopic colorectal surgery by specific light band.
Scientific Title
The research for laparoscopic navigation surgery by specific light band in colorectal operation.
Scientific Title:Acronym
The resarch for laparoscopic colorectal surgery by specific light band.
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop for cancer staging in laparoscopic colorectal operation by NBI observation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To develop for accuracy in TNM classification in colorectal cancer during operation
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.histopathological colorectal cancer
2.more than 20 years old
3.no chemotherapy
4.informed consent
Key exclusion criteria
1.having serious psycho-neurologic disease
2.inappropriate judgement for study by clinical investigator
Target sample size
67
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoh Takei |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
yohtakei@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoh Takei |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
yohtakei@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University, School of Medicine
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
| 2015 | Year | 02 | 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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observational research of NBI observation for colorectal tumor during operation
Management information
Registered date
| 2015 | Year | 02 | Month | 05 | Day |
Last modified on
| 2017 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018815
