Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis (APPEAL-GC)

Peking University

Status: Unknown

Conditions: Intraabdominal Infections; Complication; Gastrointestinal Cancer; Inflammatory Response; Anastomotic Leak

Study type: Observational

Funder types: Other

Identifiers

NCT03862378

2016YJZ32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned surgery for gastric or colorectal cancer with primary anastomosis.
• Inform consent signed before surgery.

Exclusion criteria

• No drainage tube placed.

Trial design

100 participants in 1 patient group

Group One

Description:

All patients underwent gastric or colorectal cancer surgery in the participating centers will be included. Clinical data, drainage cytokine levels will be recorded.