Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03862378
Status:
UNKNOWN
Last Update Posted:
2019-06-11
First Post:
2019-01-31
Brief Title:
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis After Gastrointestinal Cancer Surgery
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPEAL-GC
Brief Summary:
In our previous study a nomogram model was established to predict intra-abdominal infectious complications after gastrointestinal surgery This model was based on the clinical data and the drainage fluid cytokine levels and it received an AUC 09 In this study validation of this nomogram is planned to be conducted in this prospective cohort study
Detailed Description:
Intra-abdominal infectious complications such as anastomotic leakage are the most feared but common complications after gastrointestinal surgery In our previous study a nomogram model was established to predict intra-abdominal complications after gastrointestinal surgery This model was based on the clinical data and the drainage fluid cytokine levels and it received an AUC 09 A predicting score ie APPEAL-GC score was created based on the model In this study validation of this score in predicting intra-abdominal complications is planned to be conducted in this prospective cohort study
In this study all patients undergoing gastric or colorectal cancer surgery with a primary anastomosis will be included The clinical data and complication data will be prospectively collected the discarded drainage fluid will be collected and analyzed afterward No additional intervention will be applied
The cytokine levels in the drainage fluid will be evaluated and together with the clinical data an APPEAL-GC score will be created for each patient We will investigate whether the above-mentioned score is able to predict the intraabdominal complications after surgery The predictive value clinical usefulness of the score will be validated in this study
In this study all patients undergoing gastric or colorectal cancer surgery with a primary anastomosis will be included The clinical data and complication data will be prospectively collected the discarded drainage fluid will be collected and analyzed afterward No additional intervention will be applied
The cytokine levels in the drainage fluid will be evaluated and together with the clinical data an APPEAL-GC score will be created for each patient We will investigate whether the above-mentioned score is able to predict the intraabdominal complications after surgery The predictive value clinical usefulness of the score will be validated in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None