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NCT Number: NCT03408795

Assessing the Surgical Skills of Trainees in Learning the LDG

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.

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Key information

Conditions

Gastrostomy Assessment, Self Surgical Procedure, Unspecified

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic distal gastrectomy

Procedure

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

Primary outcomes

  1. Assessing the development of surgical skill by JORS-DG in the initial experience of LDG.

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Nagasaki University

Other

Collaborators

  • Hokkaido University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 24, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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