Assessing the Surgical Skills of Trainees in Learning the LDG

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrostomy; Surgical Procedure, Unspecified; Assessment, Self
• Intervention / Treatment: Procedure: Laparoscopic distal gastrectomy

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: JORS-LDG Group; Participants in JORS-LDG Group score the performance of procedure after LDG.	Procedure: Laparoscopic distal gastrectomy; Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Nagasaki University
• Collaborators: Hokkaido University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (ACTUAL): January 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 15122118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No