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Completed

NCT Number: NCT05999019

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic surgery

Procedure

robotic surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. Objective Structured Assessment of Technical Skill (OSATS)

    Time frame: 1 months

    Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)

  2. 3-year overall survival

    Time frame: 36 months

    Overall survival (OS) was calculated from the date of surgery to death from any cause or the last follow-up.

  3. 3-year disease-free survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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