(SPARROW) Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple’s procedure (SPARROW): a multicenter, randomized controlled trial

Conditions

Pancreatoduodenectomy with a high risk for contaminated bile

Brief summary

To evaluate the additional value of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile (patients with preoperative biliary drainage or an ampullary malignancy).

Detailed description

Rate of OSIs according to the CDC definition, Rate of isolated OSIs (OSIs without concurrent anastomotic leak), Rate of superficial SSIs (wound infections), Rate of clinically relevant POPF, Rate of bile and enteric leak, Rate of post pancreatectomy hemorrhage, Rate of delayed gastric emptying, Rate of postoperative bacteraemia, Rate of Clostridium difficile infection, Rate of major complications (Clavien-Dindo ≥III), Reintervention (either surgical, radiological of endoscopic), ICU admission, Length of hospital stay, Readmission, Mortality, Switch of postoperative antibiotics, Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites, Concordance of microorganisms in bile and surgical site cultures, Rate of chyle leak according to the ISGPS definition.

Related papers

No related papers found yet.

Interventions

DRUGMetronidazol 5 mg/ml Fresenius

DRUGinfusievloeistof

DRUGCefuroxim Hikma 1500 mg poeder voor oplossing voor injectie of infusie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the additional value of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile (patients with preoperative biliary drainage or an ampullary malignancy).	—

Secondary

Measure	Time frame
Rate of OSIs according to the CDC definition, Rate of isolated OSIs (OSIs without concurrent anastomotic leak), Rate of superficial SSIs (wound infections), Rate of clinically relevant POPF, Rate of bile and enteric leak, Rate of post pancreatectomy hemorrhage, Rate of delayed gastric emptying, Rate of postoperative bacteraemia, Rate of Clostridium difficile infection, Rate of major complications (Clavien-Dindo ≥III), Reintervention (either surgical, radiological of endoscopic), ICU admission, Length of hospital stay, Readmission, Mortality, Switch of postoperative antibiotics, Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites, Concordance of microorganisms in bile and surgical site cultures, Rate of chyle leak according to the ISGPS definition.	—

Measure

Time frame

Rate of OSIs according to the CDC definition, Rate of isolated OSIs (OSIs without concurrent anastomotic leak), Rate of superficial SSIs (wound infections), Rate of clinically relevant POPF, Rate of bile and enteric leak, Rate of post pancreatectomy hemorrhage, Rate of delayed gastric emptying, Rate of postoperative bacteraemia, Rate of Clostridium difficile infection, Rate of major complications (Clavien-Dindo ≥III), Reintervention (either surgical, radiological of endoscopic), ICU admission, Length of hospital stay, Readmission, Mortality, Switch of postoperative antibiotics, Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites, Concordance of microorganisms in bile and surgical site cultures, Rate of chyle leak according to the ISGPS definition.

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Countries

Netherlands

Outcome results

None listed