UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of an objective evaluation tool to assess technical skill in laparoscopic colorectal surgery
Title of the study (Brief title)	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	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
Address	Yatsuyamada 7-161, Kooriyama city, Fukushima, Japan
TEL	024-934-5322
Email	nakayama.fd3s@gmail.com

Public contact
Name of contact person	Yujiro Nakayama
Organization	South Tohoku General Hospital
Division name	Department of Surgery
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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