Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT05999019
• Lead Sponsor: Fujian Medical University

Brief 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).

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 Timeline

• Study Start: 2016-08-01
• Primary Completion: 2019-09-30
• Study Completion: 2023-06-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-11
• Last Update Submitted: 2023-08-11
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ClassIntra grade	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

Secondary Outcome Measures

Name	Time	Method
3-year overall survival	36 months	Overall survival (OS) was calculated from the date of surgery to death from any cause or the last follow-up.
3-year disease-free survival	36 months	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.
Objective Structured Assessment of Technical Skill (OSATS)	1 months	Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)