Patients with preoperative biliary stent treated by pancreaticoduodenectomy
Conditions
Brief summary
The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.
Detailed description
Infectious complications at post-operative day 90 Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90 Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria Readmission rates at post-operative day 90 Duration of hospitalization, Correlation between post-operative bacteriological samples and intraoperative bile samples, Bacteriological resistance profiles, Incidence of fungal contamination, Correlation between bacteriological and fungal contaminations, Incremental cost per infectious complications avoided
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Infectious complications at post-operative day 90 Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90 Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria Readmission rates at post-operative day 90 Duration of hospitalization, Correlation between post-operative bacteriological samples and intraoperative bile samples, Bacteriological resistance profiles, Incidence of fungal contamination, Correlation between bacteriological and fungal contaminations, Incremental cost per infectious complications avoided | — |
Countries
France