Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999019
• Other study ID #: RGiAE-01
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2023
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: June 1, 2023
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• robotic surgery
robotic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Structured Assessment of Technical Skill (OSATS)	Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)	1 months
Secondary	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
Secondary	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