Gastric CancerNCT05585437
Effect of Gastric Cancer Specialist Training Program in Laparoscopic Gastric Cancer Surgery（STP-LRG-1）
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
To prospectively evaluate the effect of the gastric cancer specialist training program of Fujian Medical University Union Hospital on laparoscopic gastric cancer surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- gastric cancer specialist training program
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to 25 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants were gastric cancer specialists who trained in the Department of Gastric Surgery of FJMU-UH from 2013 to 2020
Who may be able to join
- The title of fellow physician or above, with experience in performing laparoscopic radical gastrectomy for gastric cancer independently or under supervision;
- The hardware facilities and staffing of the operating room support the completion of laparoscopic gastric cancer surgery;
- Surgical videos of laparoscopic radical gastrectomy before and after the training required for this study can be provided;
- Clinicopathological data, intraoperative and postoperative short-term outcome data of the patients operated by the surgeon before and after training can be provided;
- Informed consent
Who cannot join
- Refuse to carry out laparoscopic gastric cancer surgery;
- Due to the limitations of equipment or policies, the unit cannot routinely carry out laparoscopic gastric cancer surgery;
- Those who have not performed laparoscopic gastric cancer surgery within 1 month before participating in the training and cannot provide video;
- Those who are not expected to perform laparoscopic gastric cancer surgery within 1 month after participating in the training;
- Participate in other clinical investigators during the same period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gastric Cancer Specialist Training Program in Laparoscopic Gastric Cancer Surgery: a Survey Based on Follow-up Questionnaire
To prospectively evaluate the effect of the gastric cancer specialist training program of Fujian Medical University Union Hospital on laparoscopic gastric cancer surgery.
Read the detailed description
Laparoscopic gastric cancer surgery has the advantages of less trauma, quick postoperative recovery, less postoperative pain symptoms, less postoperative complications, and shorter average hospital stay. In addition, the surgical safety and oncological efficacy of laparoscopic radical gastrectomy for gastric cancer have been obtained. Confirmed by numerous clinical studies.
However, due to the difficult operation, complex anatomy and high technical requirements of laparoscopic gastric cancer surgery, the operator needs to have rich experience in laparotomy, skilled laparoscopic operation skills, and the ability to actively prevent and deal with complications after surgery. Therefore, at this stage, laparoscopic radical gastrectomy for gastric cancer is only suitable for large hospitals with certain conditions, and it should be gradually carried out on the basis of chief surgeons with rich clinical experience in radical gastrectomy and skilled laparoscopic technical experience.
The gastric cancer specialist training program (STP-LRG-1) of Fujian Medical University Affiliated Union Hospital (STP-LRG-1) has more than 9 years of trainee training experience. The effectiveness of STP-LRG-1 has not been prospectively evaluated, so this study aimed to prospectively evaluate whether STP-LRG-1 can improve the surgical skills of trainees and ultimately improve short-term outcomes for patients during and after surgery
- Conditions
- Gastric Cancer
- Being tested
- gastric cancer specialist training program
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric cancer specialist training programProcedure or surgery
The gastric cancer specialist training program includes technical training and non-technical training. The technical training includes 1. The whole process of laparoscopic gastric cancer surgery technical teaching 2. Operation practice 3. Operation video review, non-technical training includes 1. Difficult case discussion 2. Specialists Session 3. Lymph node sorting training.
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer specialist training program | Not described Receives: Procedure: gastric cancer specialist training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient complication rate
Rate of reduction in surgical patient complications after trainee training
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start11 Nov 2021
- Primary completion10 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585437
- Sponsor's protocol ID
- FUGES-026
- Status last verified
- Oct 2022
- First submitted
- 22 Feb 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Cancer Specialist Training Program in Laparoscopic Gastric Cancer Surgery: a Survey Based on Follow-up Questionnaire
- ClinicalTrials.gov ID
- NCT05585437
- Acronym / sponsor ID
- FUGES-026
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 18 Oct 2022 (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.
To prospectively evaluate the effect of the gastric cancer specialist training program of Fujian Medical University Union Hospital on laparoscopic gastric cancer surgery.
Detailed description
Laparoscopic gastric cancer surgery has the advantages of less trauma, quick postoperative recovery, less postoperative pain symptoms, less postoperative complications, and shorter average hospital stay. In addition, the surgical safety and oncological efficacy of laparoscopic radical gastrectomy for gastric cancer have been obtained. Confirmed by numerous clinical studies.
However, due to the difficult operation, complex anatomy and high technical requirements of laparoscopic gastric cancer surgery, the operator needs to have rich experience in laparotomy, skilled laparoscopic operation skills, and the ability to actively prevent and deal with complications after surgery. Therefore, at this stage, laparoscopic radical gastrectomy for gastric cancer is only suitable for large hospitals with certain conditions, and it should be gradually carried out on the basis of chief surgeons with rich clinical experience in radical gastrectomy and skilled laparoscopic technical experience.
The gastric cancer specialist training program (STP-LRG-1) of Fujian Medical University Affiliated Union Hospital (STP-LRG-1) has more than 9 years of trainee training experience. The effectiveness of STP-LRG-1 has not been prospectively evaluated, so this study aimed to prospectively evaluate whether STP-LRG-1 can improve the surgical skills of trainees and ultimately improve short-term outcomes for patients during and after surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric cancer specialist training program | – | Procedure: gastric cancer specialist training program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were gastric cancer specialists who trained in the Department of Gastric Surgery of FJMU-UH from 2013 to 2020
Key inclusion criteria (5 listed)
- The title of fellow physician or above, with experience in performing laparoscopic radical gastrectomy for gastric cancer independently or under supervision;
- The hardware facilities and staffing of the operating room support the completion of laparoscopic gastric cancer surgery;
- Surgical videos of laparoscopic radical gastrectomy before and after the training required for this study can be provided;
- Clinicopathological data, intraoperative and postoperative short-term outcome data of the patients operated by the surgeon before and after training can be provided;
- Informed consent
Key exclusion criteria (5 listed)
- Refuse to carry out laparoscopic gastric cancer surgery;
- Due to the limitations of equipment or policies, the unit cannot routinely carry out laparoscopic gastric cancer surgery;
- Those who have not performed laparoscopic gastric cancer surgery within 1 month before participating in the training and cannot provide video;
- Those who are not expected to perform laparoscopic gastric cancer surgery within 1 month after participating in the training;
- Participate in other clinical investigators during the same period.
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 |
|---|---|---|
| gastric cancer specialist training programThe gastric cancer specialist training program includes technical training and non-technical training. The technical training includes 1. The whole process of laparoscopic gastric cancer surgery technical teaching 2. Operation practice 3. Operation video review, non-technical training includes 1. Difficult case discussion 2. Specialists Session 3. Lymph node sorting training. | Procedure or surgery | gastric cancer specialist training program |
Primary outcome
patient complication rate
Time frame: one year
Rate of reduction in surgical patient complications after trainee training
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 18 Oct 2022.
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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?
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
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 5 inclusion and 5 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 18 Oct 2022. 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 China. 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?
patient complication rate (time frame: one year). 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 18 Oct 2022.