Impact of Preoperative VFA on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy

NCT06506331 | Completed DMC

• 1 other identifier: 2024KY088
• Study Type: observational
• Target: 490
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preoperative visceral fat area (VFA) is associated with an increased incidence of postoperative complications in gastric cancer (GC). However, the relationship between VFA and intraoperative adverse events (iAEs) remains unclear. Therefore, this study aimed to evaluate the impact of preoperative VFA on iAEs in patients undergoing laparoscopic radical gastrectomy for GC, using data from two prospective trials. Simultaneously, a predictive model for iAEs was constructed to provide a basis for the early identification of high-risk populations and the implementation of personalized perioperative management measures.

Conditions

Gastric Cancer

Keywords

gastric cancer; intraoperative adverse events; complications; visceral fat area; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• intraoperative adverse events(iAEs)

  Intraoperative adverse events (iAEs) are important indicators for evaluating surgical quality and encompass a range of circumstances such as intraoperative bleeding, injury, and anesthesia-related events that may impact postoperative outcomes

  During surgery

Secondary Outcomes (1)

• Postoperative complications

  30 days after surgery

Study Arms (2)

high-VFA

VFA≥74 cm2

low-VFA

VFA\<74 cm2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A post hoc analysis was performed using data from two previous prospective studies (\[NCT02327481\] and \[NCT01609309\]).

You may qualify if:

• This study comprised two prospective trials conducted at Fujian Medical University Union Hospital (FMUUH): the FUGES-001 study (ClinicalTrials.gov, NCT02327481) and a subset of the CLASS-01 multicenter study (ClinicalTrials.gov, NCT01609309)

You may not qualify if:

• open surgery;
• non-adenocarcinoma gastric cancers
• Palliative surgery
• Exploratory operation
• CT data missing

Sponsors & Collaborators

• Fujian Medical University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Changming Huang, PhD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: December 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: February 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share