NCT05999019

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

August 6, 2023

Last Update Submit

August 11, 2023

Conditions

Gastric Cancer

Keywords

gastric cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Objective Structured Assessment of Technical Skill (OSATS)

    1 months

  • 3-year overall survival

    36 months

  • 3-year disease-free survival

    36 months

Interventions

robotic surgeryPROCEDURE

robotic surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Intraoperatively existing distant metastases
  • Neoadjuvant chemotherapy
  • Missing general and video data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of gastric surgery

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 21, 2023

Study Start

August 1, 2016

Primary Completion

September 30, 2019

Study Completion

June 1, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08