Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer

NCT ID: NCT05999019

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2023-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

robotic surgery

robotic surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chang-Ming Huang, Prof.

Director of gastric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RGiAE-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.