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CompletedNCT03408795Updated Jan 5, 2021

Assessing the Surgical Skills of Trainees in Learning the LDG

An interventional study of Laparoscopic distal gastrectomy in Gastrostomy, Surgical Procedure, Unspecified and Assessment, Self, sponsored by Nagasaki University. Completed at 1 site in Japan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Nagasaki University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
20 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrostomy
  • Surgical Procedure, Unspecified
  • Assessment, Self
03

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • postoperative conditions affecting LDG
  • pregnancy
  • advanced gastric cancer
  • D1 lymphadenectomy
  • Total or subtotal gastrectomy
  • unsuitable condition
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Other
    JORS-LDG Group

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

    Procedure: Laparoscopic distal gastrectomy

Interventions

  • ProcedureLaparoscopic distal gastrectomy

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

05

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

06

Study locations

1 site
  • Nagasaki University Hospital
    Nagasaki, 852-8501, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03408795
Lead sponsor
Nagasaki University
Collaborators
Hokkaido University
Responsible party
Kobayashi Shinichiro (Principal Investigator, Department of Surgery, Nagasaki University) — Principal investigator
First posted
Jan 24, 2018
Start date
Feb 1, 2016
Primary completion
Mar 30, 2019
Completion
Mar 30, 2020
Last update
Jan 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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