GastrostomyNCT03408795
Assessing the Surgical Skills of Trainees in Learning the LDG
A study testing Laparoscopic distal gastrectomy in people with Gastrostomy and Surgical Procedure, Unspecified, run by Nagasaki University at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Gastrostomy, Surgical Procedure, Unspecified, Assessment, Self
- What is being tested?
- Laparoscopic distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteJapan
- Study dates
- 1 Feb 2016to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic distal gastrectomy to early gastric cancer
- D1 plus or D2 lymphadenectomy
- Provide signed informed consent
Who cannot join
- postoperative conditions affecting LDG
- pregnancy
- advanced gastric cancer
- D1 lymphadenectomy
- Total or subtotal gastrectomy
- unsuitable condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Laparoscopic distal gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic distal gastrectomyProcedure or surgery
Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| JORS-LDG Group | Other | Participants in JORS-LDG Group score the performance of procedure after LDG. Receives: Procedure: Laparoscopic distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: Participants will be followed for the duration of the educational study for 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Feb 2016
- Primary completion30 Mar 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Collaborators
- Hokkaido University
- Responsible party
- Principal investigator, Kobayashi Shinichiro, Nagasaki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408795
- Sponsor's protocol ID
- 15122118
- Status last verified
- Dec 2020
- First submitted
- 8 Jan 2018
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Surgical Skills of Trainees in Learning the Laparoscopic Distal Gastrectomy
- ClinicalTrials.gov ID
- NCT03408795
- Acronym / sponsor ID
- 15122118
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Collaborators
- Hokkaido University
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JORS-LDG Group | Other | Procedure: Laparoscopic distal gastrectomyParticipants in JORS-LDG Group score the performance of procedure after LDG. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laparoscopic distal gastrectomy to early gastric cancer
- D1 plus or D2 lymphadenectomy
- Provide signed informed consent
Key exclusion criteria (6 listed)
- postoperative conditions affecting LDG
- pregnancy
- advanced gastric cancer
- D1 lymphadenectomy
- Total or subtotal gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic distal gastrectomyLongitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy | Procedure or surgery | JORS-LDG Group |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic distal gastrectomy in people with Gastrostomy and Surgical Procedure, Unspecified, run by Nagasaki University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.