UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021986 |
|---|---|
| Receipt number | R000025339 |
| Scientific Title | Evaluation on the accuracy of the navigation system in laparoscopic colorectal surgery. |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2019/04/26 16:32:51 |
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Basic information
Public title
Evaluation on the accuracy of the navigation system in laparoscopic colorectal surgery.
Acronym
Evaluation on the accuracy of the navigation system in laparoscopic colorectal surgery.
Scientific Title
Evaluation on the accuracy of the navigation system in laparoscopic colorectal surgery.
Scientific Title:Acronym
Evaluation on the accuracy of the navigation system in laparoscopic colorectal surgery.
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of navigation system in laparoscopic colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
target registration error(TRE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To measure the registration error in the target point indicated by laparoscopic forceps with infra-red tracking system.
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) Patients with descending/sigmoid /rectal cancer
2) Laparoscopic primary tumor resection and D3 lymph nodes dissection
3) CT after admission
4) Written IC
Key exclusion criteria
1) Emergency operation
2) Pregnant
3) Sever heart/respiratory failure
4) Ineligible cases
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Sakai |
Organization
Kyoto University
Division name
Division of Gastrointestinal Surgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3650
ysakai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Okada |
Organization
Kyoto University
Division name
Division of Gastrointestinal Surgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
t.okada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan society of Laparoscopic Colorectal Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital, Ethics Committe
Address
Konoe-cyo, Sakyo-ku yoshida, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2016 | Year | 05 | Month | 09 | 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
2
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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025339
