Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

August 11, 2023 updated by: Chang-Ming Huang, Prof., Fujian Medical University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Structured Assessment of Technical Skill (OSATS)
Time Frame: 1 months
Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)
1 months
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.
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGiAE-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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