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NCT Number: NCT06506331

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. intraoperative adverse events(iAEs)

    Time frame: 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 outcomes

  1. Postoperative complications

    Time frame: 30 days after surgery

    Postoperative complications were evaluated according to the Clavien-Dindo classification and categorized as surgical or medical

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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