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

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT06506331
• Lead Sponsor: Fujian Medical University

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.

Detailed 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.

Study Timeline

• Study Start: 2012-12-01
• Primary Completion: 2016-04-01
• Study Completion: 2024-02-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intraoperative adverse events(iAEs)	During surgery	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

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery	Postoperative complications were evaluated according to the Clavien-Dindo classification and categorized as surgical or medical