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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035174
Receipt No. 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

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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
Email 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
Email nakayama.fd3s@gmail.com

Sponsor
Institute South Tohoku General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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