Probiotics Combined with Enteral Nutrition on Infectious Complications After Pancreaticoduodenectomy:a Single-centre, Prospective Randomised, Open, Parallel-controlled, Superiority Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- infectious complication
研究概览
简要总结
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients greater than 18 years of age;
- •Indication for elective pancreaticoduodenal surgery;
- •Patients who understand the nature of the trial and are willing and able to provide written consent
排除标准
- •. Current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications.
- •Inability to tolerate PD due to cardiopulmonary function and other parameters
- •Received radiotherapy before surgery
- •Emergency PD surgery
- •Pregnant and breastfeeding women
研究组 & 干预措施
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD
enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID
干预措施: Bifidobacterium Bifidum Oral Capsule (Drug)
结局指标
主要结局
infectious complication
时间窗: 30 days after surgery
1. Post-operative infections: Surgical site infections (SSI): including surgical incision infections and abdominal cavity infections. (1) incision infection: purulent secretions in the incision and culture of pathogenic bacteria (2) abdominal cavity infection: diagnosis can be made by meeting one of the following criteria: ① postoperative symptoms of systemic infection (fever \> 38 ° C, white blood cell count higher than the upper limit of normal values), accompanied by abdominal distension, abdominal pain, and signs of peritonitis; ② abdominal drainage or puncture drainage fluid is purulent fluid, positive bacteriological culture results; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess in the abdominal cavity; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess. (iii) ultrasound or CT imaging or re-surgical confirmation of the presence of intra-abdominal ex
次要结局
未报告次要终点