UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035174 |
|---|---|
| Receipt number | R000040089 |
| Scientific Title | Development of an objective evaluation tool to assess technical skill in laparoscopic colorectal surgery |
| Date of disclosure of the study information | 2018/12/07 |
| Last modified on | 2018/12/07 20:34:01 |
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Basic information
Public title
Development of an objective evaluation tool to assess technical skill in laparoscopic colorectal surgery
Acronym
An objective evaluation tool for laparoscopic colorectal surgery
Scientific Title
Development of an objective evaluation tool to assess technical skill in laparoscopic colorectal surgery
Scientific Title:Acronym
An objective evaluation tool for laparoscopic colorectal surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of evaluation tool for operative technic in laparoscopic sigmoidectomy and right hemicolectomy.
Basic objectives2
Others
Basic objectives -Others
Development precise evaluation tool by a Delphi methodology.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation tool by a Delphi methodology
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Expert surgeons who have Endoscopic surgical skill qualification system: qualified surgeon in Japan Society of Endoscopic Surgery, and currently practicing surgeons who are involved in training laparoscopic colorectal surgery both at the resident and continuing professional development level.
Key exclusion criteria
Expert surgeons who have not Endoscopic surgical skill qualification system: qualified surgeon in Japan Society of Endoscopic Surgery.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yujiro Nakayama |
Organization
1. General South Tohoku Hospital
2. Fukushima Medical University
Division name
1. Department of Surgery 2. Department of Minimally Invasive Surgery and Medical Oncology
Zip code
Address
Yatsuyamada 7-161, Kooriyama city, Fukushima, Japan
TEL
024-934-5322
nakayama.fd3s@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yujiro Nakayama |
Organization
South Tohoku General Hospital
Division name
Department of Surgery
Zip code
Address
Yatsuyamada 7-161, Kooriyama city, Fukushima, Japan
TEL
024-934-5322
Homepage URL
nakayama.fd3s@gmail.com
Sponsor or person
Institute
South Tohoku General 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
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
| 2018 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
The experts was recruited within September 1 2018 to December 1 2018. The experts will be recruited and communicated with over e-mail.
Management information
Registered date
| 2018 | Year | 12 | Month | 07 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040089
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
