Clinical trial NCT03862378: Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis
Official title: Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis After Gastrointestinal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication
Anastomotic Leak
Intraabdominal Infections
Inflammatory Response
Gastrointestinal Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This observational study intends to include all patients undergoing gastric or colorectal cancer with primary anastomosis. Because drainage fluid analysis is necessary for the prediction model, patients without the tube will be excluded.

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 \>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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No drainage tube placed.

Primary outcomes:
measure: Predictive value of the nomogram prediction model (APPEAL-GC score)
timeFrame: From surgery until discharge, up to 90 days.
Secondary outcomes:
measure: Abdominal infection rate.
timeFrame: From surgery until discharge, up to 90 days.
measure: Abdominal infection outcome.
timeFrame: From surgery until discharge, up to 90 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziyu Li, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: