BMJ open · 2025
PERIoperative antibiotic prophylaxis in PANCreatic surgery (PeriPANC): protocol for a prospective observational study comparing antibiotic regimens and their impact on postoperative outcomes in pancreatic surgery.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Weber Sophie, Siegel Niels, Hank Thomas, Halm Darius, Kinny-Köster Benedict, Heckler Max, Harnoss Jonathan M, Al-Saeedi Mohammed, Probst Pascal, Michalski Christoph W, Loos Martin, Harnoss Julian C
Аннотация
INTRODUCTION: Despite advancements in pancreatic surgery, postoperative infections-particularly surgical site infections (SSIs), which occur in 6-17% of cases-continue to be a leading cause of morbidity. Effective perioperative antibiotic prophylaxis is essential, though the optimal regimen remains unclear. Recent studies indicate that broad-spectrum antibiotics may be more effective than cephalosporins; however, agents like piperacillin/tazobactam, despite broader coverage, pose risks of resistance development and increased costs.
METHODS AND ANALYSIS: The PERIoperative antibiotic prophylaxis in PANCreatic surgery (PeriPANC) study is a single-centre, prospective, observational study investigating the effectiveness of piperacillin/tazobactam for perioperative antibiotic prophylaxis in pancreatic surgery, compared with a retrospective cohort previously treated with ampicillin/sulbactam. Around 300 adult patients undergoing pancreatic resection will be included. The primary outcome is the incidence of SSI; secondary outcomes include other infectious complications, microbial resistance and healthcare utilisation. Differences between groups will be analysed with analysis of covariance.
ETHICS AND DISSEMINATION: The PeriPANC study has been reviewed and approved by the local ethics committee of Heidelberg University Hospital (S-087/2025). As all patients receive standard care and no additional data are collected beyond routine documentation, informed consent is not required. Findings will be disseminated through peer-reviewed publications. The results are expected to inform clinical practice and guideline development in the field of perioperative infection prevention in pancreatic surgery.
TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS): DRKS00036546.
METHODS AND ANALYSIS: The PERIoperative antibiotic prophylaxis in PANCreatic surgery (PeriPANC) study is a single-centre, prospective, observational study investigating the effectiveness of piperacillin/tazobactam for perioperative antibiotic prophylaxis in pancreatic surgery, compared with a retrospective cohort previously treated with ampicillin/sulbactam. Around 300 adult patients undergoing pancreatic resection will be included. The primary outcome is the incidence of SSI; secondary outcomes include other infectious complications, microbial resistance and healthcare utilisation. Differences between groups will be analysed with analysis of covariance.
ETHICS AND DISSEMINATION: The PeriPANC study has been reviewed and approved by the local ethics committee of Heidelberg University Hospital (S-087/2025). As all patients receive standard care and no additional data are collected beyond routine documentation, informed consent is not required. Findings will be disseminated through peer-reviewed publications. The results are expected to inform clinical practice and guideline development in the field of perioperative infection prevention in pancreatic surgery.
TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS): DRKS00036546.