(SPARROW) Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple’s procedure (SPARROW): a multicenter, randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 421
- 试验地点
- 12
- 主要终点
- 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).
研究概览
简要总结
The primary endpoint is the occurrence of a clinically relevant OSI and must meet the following criteria (based on the CDCdefinition): • A deep surgical site infection involving any part of the abdomen (e.g. organs and/or spaces) other than the surgical incision within90 days after surgery. • AND Requires radiological, endoscopic or surgical intervention OR therapeutic antibiotics required for an episode of sepsis,defined as two or more SIRS criteria. • AND Organisms isolated from an aseptically obtained culture.
研究设计
- 分配方式
- Randomized
- 主要目的
- Multicenter, randomized controlled, superiority trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy.
- •Age >18 years
排除标准
- •Contraindication for the study antibiotics (e.g. allergy or intolerance)
- •Indication for endocarditis prophylaxis
- •Preoperative planned therapeutic antibiotic treatment after surgery (i.e. for cholangitis or liver abscesses)
- •A reduced renal function, defined as a eGFR of <60 ml/min/1.73m2 and measured on a the closest timepoint prior to pancreatoduodenectomy
结局指标
主要结局
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).
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).
次要结局
- 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.
研究者
Clinical Research Center, dept. of Surgery
Scientific
Academisch Ziekenhuis Leiden