Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Appraisal of Surgical Outcomes and Oncological Efficiency of Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: robotic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Intraoperatively existing distant metastases Neoadjuvant chemotherapy Missing general and video data.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: robotic surgery|robotic surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Structured Assessment of Technical Skill (OSATS) | Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS) | 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. | 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. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer