Clinical trial · Observational
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis
Prediction of Intra-abdominal Infectious Complication by Drainage Fluid Analysis After Gastrointestinal Cancer Surgery
NCT03862378CI-TRIAL-00039021APPEAL-GCunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Complication | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Inflammatory Response | — | UNRESOLVED | — |
| Intraabdominal Infections | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 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.
Primary outcomes (1)
- measure
- Predictive value of the nomogram prediction model (APPEAL-GC score)
- timeFrame
- From surgery until discharge, up to 90 days.
- description
- The positive predictive value of the APPEAL-GC score in predicting the intra-abdominal infectious complications. Intra-Abdominal infectious complications include anastomotic leakage and other abdominal infectious complications. The complication definitions are in accordance with the Chinese consensus of gastrointestinal complication diagnosis and registration. The APPEAL-GC score was derived from our recently finished study (unpublished). It includes evaluation of the surgical type (open or laparoscopic), resection range, age, and cytokine levels on the postoperative day 3. A score of each patient can be determined, and a pre-set cut-off value (unpublished data) was determined in our previous study based on the AUC analysis. In this study, each patient will be scored accordingly. The positive predictive value and negative predictive value of the cut-off value will be evaluated.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Planned surgery for gastric or colorectal cancer with primary anastomosis. * Inform consent signed before surgery. Exclusion Criteria: * No drainage tube placed.
References
Publications (0)
Data not yet available
No reference posted for this study.