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

Fujian Medical University

Status: Completed

Conditions: Gastric Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06506331

2024KY088

Details and patient eligibility

About

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.

Full description

A post hoc analysis was performed using data from two previous prospective studies ([NCT02327481] and [NCT01609309]). The patients were divided into high- and low-VFA groups. All iAEs were reviewed from the surgical videos and graded using ClassIntra. Logistic regression analyses were used for the construction of nomograms as predictive models.

Enrollment: 490 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

1. open surgery;
2. non-adenocarcinoma gastric cancers
3. Palliative surgery
4. Exploratory operation
5. CT data missing

Trial design

490 participants in 2 patient groups

high-VFA

Description:

VFA≥74 cm2

low-VFA

Description:

VFA\<74 cm2