Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Event rate
研究概览
简要总结
The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation.
Research hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed diagnosis of very high risk non muscle-invasive bladder carcinoma (cT1NoMo) or muscle-invasive bladder carcinoma (cT2-T4NxM0) with or without neoadjuvant therapy (chemotherapy or immunotherapy are both possible);
- •patient should be eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy or hysterectomy if applicable) according to surgeon opinion;
- •pelvic lymph node dissection is engaged in two possible variants: extended level to intersection of ureter and iliac vessels; superextended level - up to aortic bifurcation;
- •urinary diversion is engaged in two possible variants: orthotopic diversion (J- or U-pouch reservoirs), heterotopic diversion in the Mainz-I modification, Bricker;
- •male or female is at least 18 years old at the time of signing the informed consent form;
- •female patient is eligible to participate if she is not pregnant, not breastfeeding;
- •ECOG performance status of 0 or 1;
- •adequate organ function (in accordance with laboratory standards);
- •used valid protocol for Enhanced Recovery After Surgery (ERAS protocol) at Hospital (oncourological department);
排除标准
- •known additional non-urothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions;
- •diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug;
- •replacement doses of corticosteroids are permitted for participants with adrenal insufficiency;
- •evidences of uncontrolled diseases (diabetes mellites, noninfectious pneumonitis that required steroids, et.) or any conditions which interfere with the conduct of the research procedures according to doctor opinion;
- •presence of 2 or more criteria for systemic inflammatory response syndrome (SIRS) at the time of the patient's admission to the hospital (assessment of these factors 3-7 days before randomization):
- •temperature ≥ 38˚С or ≤ 36˚С;
- •heart rate (HR) ≥ 90 / min;
- •respiratory rate < 20/min or hyperventilation (Pa CO2 ≤ 32 mm Hg);
- •blood leukocytes >12 ∙ 109 / l or < 4 ∙ 109 / l, or immature forms > 10%
- •prohibited urinary diversion when planning surgery and signing voluntary consent: diversion into continuous intestine (ureterosigmostomy, Mainz-pouch II operation);
- •inadequate organ function:
- •Neutrophils <1.5 x 10 ^ 9 / l
- •Platelets <100 x 10 ^ 9 / l
- •ALT> 3 x VGN
- •AST> 3 x VGN
- •Bilirubin> 1.5 x ULN
- •GFR level <35 ml / min
研究组 & 干预措施
Amoxicillin/ Cefuroksim
standard antibiotic prophylaxis 24 hours
干预措施: Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg (Drug)
Meropenem
preventive antibiotic therapy within 5 days from the date of the skin incision
干预措施: Meropenem 1000 mg (Drug)
结局指标
主要结局
Event rate
时间窗: 90 days after Radical cystectomy
Determine the frequency of events of clinical interest in the period 30-90 days after RC in a surgical hospital working according to the protocol for early postoperative recovery of the patient
Event-free survival
时间窗: 90 days after Radical cystectomy
Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital
次要结局
- All-cause mortality(90 days after Radical cystectomy)
- Emergence of resistant(30-90 days after Radical cystectomy)
研究者
Berkut Mariya
Principal Investigator
N.N. Petrov National Medical Research Center of Oncology