NCT03408795

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

January 8, 2018

Last Update Submit

December 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.

    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.

    Participants will be followed for the duration of the educational study for 3 years.

Study Arms (1)

JORS-LDG Group

OTHER

Participants in JORS-LDG Group score the performance of procedure after LDG.

Procedure: Laparoscopic distal gastrectomy

Interventions

Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy

JORS-LDG Group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic distal gastrectomy to early gastric cancer
  • D1 plus or D2 lymphadenectomy
  • Provide signed informed consent

You may not qualify if:

  • postoperative conditions affecting LDG
  • pregnancy
  • advanced gastric cancer
  • D1 lymphadenectomy
  • Total or subtotal gastrectomy
  • unsuitable condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Surgery

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 24, 2018

Study Start

February 1, 2016

Primary Completion

March 30, 2019

Study Completion

March 30, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations