Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506331
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Impact of Preoperative VFA on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None