Assessment of Robotic Versus Laparoscopic Gastrectomy for... | NCT06752538

Studies
Assessment of Robotic Versus Laparoscopic Gastrectomy for GC Patients With Intraoperative Technical Complexity

NCT06752538

Sponsor

Fujian Medical University

Status

Completed

Last Update Posted

Jun 11, 2025Actual

Enrollment

3,534Actual

Phase

Not provided

Conditions

Gastrectomy for Gastric Cancer
Robotic Surgical Procedures
Laparoscopic Surgical Procedures

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024KY216	Other Identifier	Fujian Medical University Union Hospital

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Jun 2019Actual

Completion Date

Jul 2024Actual

First Submitted Date

Dec 22, 2024

First Submission Date that Met QC Criteria

Dec 22, 2024

First Posted Date

Dec 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2025

Last Update Posted Date

Jun 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,534Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RG group		Patients undergoing robotic gastrectomy
LG group		Patients undergoing laparoscopic gastrectomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Telephone follow-up	Within 3 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
recurrence	Telephone follow-up	36 months
Postoperative complications	Postoperative complications were evaluated according to the Clavien-Dindo classification and categorized as surgical or medical

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang-Ming Huang, PhD	Fujian Medical University Union Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital		Fuzhou	Fujian	350001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided