NCT03862378

Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis

Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis After Gastrointestinal Cancer Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \>0.9. 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 \>0.9. A predicting score (i.e. 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.

Conditions

• Complication
• Anastomotic Leak
• Intraabdominal Infections
• Inflammatory Response
• Gastrointestinal Cancer

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-31
• Completion: 2021-12-31
• First posted: 2019-03-05
• Last updated: 2019-06-11

Locations

1 site across 1 country: China