Assessing the Surgical Skills of Trainees in Learning the LDG

Surgical Procedure, Unspecified Clinical Trial

Official title:

Assessing the Surgical Skills of Trainees in Learning the Laparoscopic Distal Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408795
• Other study ID #: 15122118
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: March 30, 2020

Study information

• Verified date: December 2020
• Source: Nagasaki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However, there is no assessment system to measuring the surgical skill of surgical trainees. The novel surgical assessment system, which called Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy (JORS-LDG) by the task analysis and the Delphi method have been developed. This study describes assessing the development of surgical skill by JORS-LDG in the initial experience of LDG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Laparoscopic distal gastrectomy to early gastric cancer

• D1 plus or D2 lymphadenectomy

• Provide signed informed consent

Exclusion Criteria:

• postoperative conditions affecting LDG

• pregnancy

• advanced gastric cancer

• D1 lymphadenectomy

• Total or subtotal gastrectomy

• unsuitable condition

Related Conditions & MeSH terms

• Assessment, Self
• Gastrostomy
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Laparoscopic distal gastrectomy
Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy

Locations

Country	Name	City	State
Japan	Nagasaki University Hospital	Nagasaki

Sponsors (2)

Lead Sponsor	Collaborator
Nagasaki University	Hokkaido University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the development of surgical skill by JORS-DG in the initial experience of LDG.	The surgical skill and performance of LDG was scored using JORS-DG by a trainee and an instructor. The difference in mean surgical performance score of JORS-DG was evaluated in tree phase. The score about JORS-DG is evaluated on a three or two level scale ( 28items in B-1 reconstruction or 31items in R-Y reconstruction). Maximum of total score is 46 in B-1 reconstruction or 52 in R-Y reconstruction. High score is good surgical skill. Low score is poor surgical skill.	Participants will be followed for the duration of the educational study for 3 years.
Secondary	Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.	Operation time, bleeding , Postoperative complications are compared with average of total score of JORS-LDG. The score about JORS-LDG is evaluated on a three or two level scale ( 28items in B-1 reconstruction or 31items in R-Y reconstruction). Maximum of total score is 46 in B-1 reconstruction or 52 in R-Y reconstruction. High score is good surgical skill. Low score is poor surgical skill.	Participants will be followed for the duration of the educational study for 3 years.
Secondary	Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.	Procedures' time in each items of LDG was evaluated for difficulty of surgical technics. The scoring rates in each items of LDG are compared with Procedures' time. The average of score about JORS-LDG is evaluated on a three or two level scale ( 28items in B-1 reconstruction or 31items in R-Y reconstruction). High score is good surgical skill. Low score is poor surgical skill.	Participants will be followed for the duration of the educational study for 3 years.