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

Impact of Preoperative Visceral Fat Area on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy: A Pooled Analysis From Two Randomized Trials

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06506331

Enrollment

490

Registered

2024-07-17

Start date

2012-12-01

Completion date

2024-02-01

Last updated

2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results