An observational study in Complication, Anastomotic Leak and Intraabdominal Infections, sponsored by Peking University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by Peking University · Observational
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.
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.
218 studies on the registry are indexed under Anastomotic Leak; 62 are open to participants now.
This study's planned enrollment of 100 is below the median of 194 across 114 observational studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Peking University is the lead sponsor of 418 studies on the registry; 122 are open to participants now.
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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.
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Exclusion Criteria:
All patients underwent gastric or colorectal cancer surgery in the participating centers will be included. Clinical data, drainage cytokine levels will be recorded.
Predictive value of the nomogram prediction model (APPEAL-GC score)
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.
Time frame: From surgery until discharge, up to 90 days.
Abdominal infection rate.
Number of anastomotic leak and other abdominal infection patients divided by the total inclusions.
Time frame: From surgery until discharge, up to 90 days.
Abdominal infection outcome.
It is categorized as cured, not cured at discharge, death. The doctor is required to select one option at patient discharge. Proportions of different outcomes will be compared.
Time frame: From surgery until discharge, up to 90 days.
Plan to share: Undecided
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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