Gastric CancerNCT05999019
Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer
An observational study of Gastric Cancer, run by Fujian Medical University.
Trial summary
Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery for gastric cancer (GC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- robotic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 366 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Jun 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study included 366 patients who underwent robotic gastrectomy at the Department of Gastrointestinal Surgery, Fujian Medical University Union Hospital, between August 2016 and September 2019, where over 800 gastrectomies were performed annually for patients with GC.
Who may be able to join
- Patients diagnosed with gastric adenocarcinoma through pathology;
- Preoperative chest radiograph, abdominal ultrasonogram, and full abdominal CT examination showed no distant metastasis to the liver, lungs, or abdominal cavity;
- Patients who underwent robotic radical gastrectomy.
Who cannot join
- Intraoperatively existing distant metastases
- Neoadjuvant chemotherapy
- Missing general and video data.
About this study
Official title: Appraisal of Surgical Outcomes and Oncological Efficiency of Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer
Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery for gastric cancer (GC).
Read the detailed description
Gastric cancer (GC) is the fifth most common malignant tumor worldwide and the fourth leading cause of cancer-related deaths. Surgery remains the cornerstone of GC treatment, and there is a significant lack of research on iAE compared with postoperative complications. Owing to the influence of reporting and cultural acceptance, there have been issues of inadequate reporting and non-standardized practices regarding iAE reporting.
The previously reported laparoscopic results showed that the ClassIntra grade is an effective prognostic and surgical quality control index for laparoscopic radical surgery for gastric cancer therefore it could be included in routine hospital care and surgical quality control. (DOI: 10.1097/SLA.0000000000005727). Here, iAEs in patients who underwent robotic radical gastrectomy significantly correlated with the occurrence of postoperative complications and a poor long-term prognosis. Therefore, utilization and inclusion of ClassIntra grading as a crucial surgical quality control and prognostic indicator in the routine surgical quality evaluation system are recommended.
- Conditions
- Gastric Cancer
- Being tested
- robotic surgery
- Keywords
- gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgeryProcedure or surgery
robotic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ClassIntra grade
Patients who experienced iAE were classified into the iAE group using ClassIntra grading (version 1.0). The iAEs were further classified into five sublevels (ranging from I to V according to severity) based on the ClassIntra grade
Measured: 1 months
Secondary outcomes (3)
Objective Structured Assessment of Technical Skill (OSATS)
Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)
Measured: 1 months
3-year overall survival
Overall survival (OS) was calculated from the date of surgery to death from any cause or the last follow-up.
Measured: 36 months
3-year disease-free survival
Disease-free survival (DFS) was calculated from the date of surgery to recurrence (locoregional and systemic), death from any cause, or the last follow-up.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Aug 2016
- Primary completion30 Sep 2019
- Study completion1 Jun 2023
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
- 366 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
- NCT05999019
- Sponsor's protocol ID
- RGiAE-01
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appraisal of Surgical Outcomes and Oncological Efficiency of Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT05999019
- Acronym / sponsor ID
- RGiAE-01
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Aug 2023 (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.
Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery for gastric cancer (GC).
Detailed description
Gastric cancer (GC) is the fifth most common malignant tumor worldwide and the fourth leading cause of cancer-related deaths. Surgery remains the cornerstone of GC treatment, and there is a significant lack of research on iAE compared with postoperative complications. Owing to the influence of reporting and cultural acceptance, there have been issues of inadequate reporting and non-standardized practices regarding iAE reporting.
The previously reported laparoscopic results showed that the ClassIntra grade is an effective prognostic and surgical quality control index for laparoscopic radical surgery for gastric cancer therefore it could be included in routine hospital care and surgical quality control. (DOI: 10.1097/SLA.0000000000005727). Here, iAEs in patients who underwent robotic radical gastrectomy significantly correlated with the occurrence of postoperative complications and a poor long-term prognosis. Therefore, utilization and inclusion of ClassIntra grading as a crucial surgical quality control and prognostic indicator in the routine surgical quality evaluation system are recommended.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study included 366 patients who underwent robotic gastrectomy at the Department of Gastrointestinal Surgery, Fujian Medical University Union Hospital, between August 2016 and September 2019, where over 800 gastrectomies were performed annually for patients with GC.
Key inclusion criteria (3 listed)
- Patients diagnosed with gastric adenocarcinoma through pathology;
- Preoperative chest radiograph, abdominal ultrasonogram, and full abdominal CT examination showed no distant metastasis to the liver, lungs, or abdominal cavity;
- Patients who underwent robotic radical gastrectomy.
Key exclusion criteria (3 listed)
- Intraoperatively existing distant metastases
- Neoadjuvant chemotherapy
- Missing general and video data.
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 |
|---|---|---|
| robotic surgeryrobotic surgery | Procedure or surgery | – |
Primary outcome
ClassIntra grade
Time frame: 1 months
Patients who experienced iAE were classified into the iAE group using ClassIntra grading (version 1.0). The iAEs were further classified into five sublevels (ranging from I to V according to severity) based on the ClassIntra grade
3 secondary outcomes
Objective Structured Assessment of Technical Skill (OSATS)
Time frame: 1 months
3-year overall survival
Time frame: 36 months
3-year disease-free survival
Time frame: 36 months
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 21 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Fujian Medical University.
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 3 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
ClassIntra grade (time frame: 1 months). 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 21 Aug 2023.