- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06752538
Assessment of Robotic Versus Laparoscopic Gastrectomy for GC Patients With Intraoperative Technical Complexity
June 6, 2025 updated by: Chang-Ming Huang, Prof., Fujian Medical University
Assessment of Robotic Versus Laparoscopic Gastrectomy for Gastric Cancer Patients With Intraoperative Technical Complexity: A Multicenter Retrospective Study
While robotic gastrectomy (RG) is increasingly used in gastric cancer surgery, its potential advantages over laparoscopic gastrectomy (LG) in Intraoperative technical complexity (ITC) cases remain debated.
Study Overview
Status
Completed
Detailed Description
This retrospective cohort study included 3,534 patients with gastric cancer who underwent radical gastrectomy at eight high-volume hospitals.
ITC was defined by any of the following criteria: operative time exceeding the third quartile, intraoperative estimated blood loss ≥ 400 mL, or conversion to open surgery.
Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were conducted to compare short- and long-term outcomes.
Study Type
Observational
Enrollment (Actual)
3534
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Fujian Medical University Union Hospital
-
-
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
Patients with pathologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent radical RG or LG between August 2016 and June 2019 at eight high-volume tertiary teaching hospitals in China
Description
Inclusion Criteria:
- Patients with postoperatively histologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent RG or LG
Exclusion Criteria:
- Remnant gastric cancer
- Previous malignant
- ASA class >3
- Use of indocyanine green
- Neoadjuvant chemotherapy
- Loss to follow-up
- Combined resection
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
Cohorts and Interventions
Group / Cohort |
|---|
|
RG group
Patients undergoing robotic gastrectomy
|
|
LG group
Patients undergoing laparoscopic gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: Within 3 years after surgery
|
Telephone follow-up
|
Within 3 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications
Time Frame: 30 days after surgery
|
Postoperative complications were evaluated according to the Clavien-Dindo classification and categorized as surgical or medical
|
30 days after surgery
|
|
recurrence
Time Frame: 36 months
|
Telephone follow-up
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chang-Ming Huang, PhD, Fujian Medical University Union Hospital
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)
June 1, 2019
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
December 22, 2024
First Submitted That Met QC Criteria
December 22, 2024
First Posted (Actual)
December 30, 2024
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 6, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024KY216 (Other Identifier: Fujian Medical University Union Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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