Gastric CancerATP-LRG-1NCT05219539
Questionnaire Survey of the Advanced Training Program for Laparoscopic Radical Gastrectomy
An observational study of Gastric Cancer, run by Fujian Medical University at 1 site in China.
Trial summary
This study aims to evaluate the outcomes of the advanced training program for laparoscopic radical gastrectomy (ATP-LRG). The research subjects are the trainees who participated in this training program. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 1,355 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to 20 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: From September 2009 to July 2021, Fujian Medical University Union Hospital have carried out 113 ATP-LRG courses, training a total of 1,447 trainees nationwide. In order to reduce recall bias, this study used an electronic questionnaire to conduct a return visit to 875 trainees who participated in the ATP-LRG for one year from January 2015 to October 2020.
Who may be able to join
- Participated in ATP-LRG between January 2015 and October 2020
- Have contact information
Who cannot join
- Repeated participation in ATP-LRG
- Refuse to fill out the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of the National Advanced Training Program for Laparoscopic Radical Gastrectomy: a Survey Based on Follow-up Questionnaire
This study aims to evaluate the outcomes of the advanced training program for laparoscopic radical gastrectomy (ATP-LRG). The research subjects are the trainees who participated in this training program.
Read the detailed description
Written informed consent is not required because of the observational and anonymous nature of this study. ATP-LRG is a national training program carried out by Fujian Medical University Union Hospital. Each training lasts about 1.5 days, which includes 1) detailed technique description; 2) prevention and solving of intraoperative complications; 3) live surgery performance; 4) theory and practice of clinical research; 5) comments on trainees' videos; and 6) questions, answers and discussions. In this study, 875 trainees who participated in ATP-LRG from January 2015 to October 2020 were interviewed using electronic questionnaires. Using a repeated-measures design to examine differences in outcomes before and after participating in the training. Questionnaire Star (Changsha Ranxing Information Technology Co., Ltd), a most widely used professional online questionnaire software platform in China, was used to design and create a link to the questionnaire. The questionnaire's link was sent to each trainee via WeChat (Tencent Holdings Limited), the most commonly used social networking software in China.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of general surgical skills score
Change of general surgical skills score = posttraining general surgical skills score - pretraining general surgical skills score. Scores were evaluated using questionares.
Measured: One year after participating in ATP-LRG
Secondary outcomes (2)
Changes of laparoscopic gastrectomy acceptance score
Changes of laparoscopic gastrectomy acceptance score = posttraining laparoscopic gastrectomy acceptance score - pretraining laparoscopic gastrectomy acceptance score. Scores were evaluated using questionares.
Measured: One year after participating in ATP-LRG
Changes of clinical research possibilities score
Changes of clinical research possibilities score= posttraining clinical research possibilities score - pretraining clinical research possibilities score. Scores were evaluated using questionares.
Measured: One year after participating in ATP-LRG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start11 Nov 2021
- Primary completion2 Dec 2021
- Study completion20 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
- 1,355 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
- NCT05219539
- Sponsor's protocol ID
- ATP-LRG-1
- Acronym
- ATP-LRG-1
- Status last verified
- May 2022
- First submitted
- 11 Jan 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of the National Advanced Training Program for Laparoscopic Radical Gastrectomy: a Survey Based on Follow-up Questionnaire
- ClinicalTrials.gov ID
- NCT05219539
- Acronym / sponsor ID
- ATP-LRG-1 / ATP-LRG-1
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 2 Feb 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.
This study aims to evaluate the outcomes of the advanced training program for laparoscopic radical gastrectomy (ATP-LRG). The research subjects are the trainees who participated in this training program.
Detailed description
Written informed consent is not required because of the observational and anonymous nature of this study. ATP-LRG is a national training program carried out by Fujian Medical University Union Hospital. Each training lasts about 1.5 days, which includes 1) detailed technique description; 2) prevention and solving of intraoperative complications; 3) live surgery performance; 4) theory and practice of clinical research; 5) comments on trainees' videos; and 6) questions, answers and discussions. In this study, 875 trainees who participated in ATP-LRG from January 2015 to October 2020 were interviewed using electronic questionnaires. Using a repeated-measures design to examine differences in outcomes before and after participating in the training. Questionnaire Star (Changsha Ranxing Information Technology Co., Ltd), a most widely used professional online questionnaire software platform in China, was used to design and create a link to the questionnaire. The questionnaire's link was sent to each trainee via WeChat (Tencent Holdings Limited), the most commonly used social networking software in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From September 2009 to July 2021, Fujian Medical University Union Hospital have carried out 113 ATP-LRG courses, training a total of 1,447 trainees nationwide. In order to reduce recall bias, this study used an electronic questionnaire to conduct a return visit to 875 trainees who participated in the ATP-LRG for one year from January 2015 to October 2020.
Key inclusion criteria (2 listed)
- Participated in ATP-LRG between January 2015 and October 2020
- Have contact information
Key exclusion criteria (2 listed)
- Repeated participation in ATP-LRG
- Refuse to fill out the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of general surgical skills score
Time frame: One year after participating in ATP-LRG
Change of general surgical skills score = posttraining general surgical skills score - pretraining general surgical skills score. Scores were evaluated using questionares.
2 secondary outcomes
Changes of laparoscopic gastrectomy acceptance score
Time frame: One year after participating in ATP-LRG
Changes of clinical research possibilities score
Time frame: One year after participating in ATP-LRG
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 10 May 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 2 inclusion and 2 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 10 May 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?
Change of general surgical skills score (time frame: One year after participating in ATP-LRG). 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 10 May 2022.