A Randomized Controlled Trials on the Effect of Necrotic Cavity Lavage After Laparoscope-assisted Debridement for Patients With Infected Pancreatic Necrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- sum rate of mortality and major complications
研究概览
简要总结
The infected pancreatic necrosis (IPN) should be treated by debridement and drainage. In recent years, the results of clinical research show that minimally invasive debridement such as video-assisted (laparoscope, nephroscope, endoscopy, etc.) and total laparoscopic debridement can significantly improve the prognosis of IPN patients. After a long period of clinical practice, laparoscope-assisted debridement was selected as the main surgical method in our center. In many large-scale clinical studies, patients after surgery underwent necrotic cavity lavage (such as small omental sac lavage, retroperitoneal space lavage, peripancreatic lavage, etc.), but its necessity and clinical significance were not clearly stated in the guidelines. At present, the clinical research mainly focuses on the improvement of minimally invasive debridement, and less on the necessity of lavage. In the past, necrotic cavity lavage was performed in IPN patients, but long-term clinical observation showed that lavage may lead to spread of infection and increase the incidence of lower extremity venous thrombosis which is not accorded with ERAS(Enhanced Recovery After Surgery). Therefore, since 2012, our center has stopped necrotic cavity lavage for IPN patients after debridement. We retrospectively analyzed the therapeutic effect from February 2014 to August 2017 and found that even without necrotic cavity lavage, better therapeutic effect could be achieved. Meanwhile it can simplify the operation process and avoid infection spread. This treatment method provides a new idea. However, it is a retrospective study not a randomized controlled trials(RCT) which is low effectiveness of proof. Therefore, we design this RCT to verify the necessity of necrotic cavity lavage after laparoscope-assisted debridement for patients with infected pancreatic necrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of IPN
- •onset time of >4 weeks
- •performance of LAD for IPN
- •provision of written informed consent
排除标准
- •the highest temperature in 24 hours of ≥38.5ºC
- •new organ failure occurring within 24 hours after the operation
- •digestive tract fistula, biliary tract or digestive tract obstruction, or bleeding occurring within 24 hours after the operation
- •abdominal pressure of ≥10 mmHg within 24 hours after the operation
- •traumatic pancreatitis or a pancreatic fistula-related infection after the pancreatic operation
结局指标
主要结局
sum rate of mortality and major complications
时间窗: 1 year
number of deaths and major complications (new organ failure or intraperitoneal hemorrhage/gastrointestinal fistula requiring surgical treatment)/total enrollment
次要结局
- Acute Physiology and Chronic Health Evaluation (range:0-71)(through study completion, an average of 2 months)
- incidence of peritonitis and lower extremity deep vein thrombosis(through study completion, an average of 2 months)
- Total stay in hospital(through study completion, an average of 2 months)
- Length of stay in Intensive Care Unit(through study completion, an average of 2 months)
- physiological parameter(through study completion, an average of 2 months)
- assay index(through study completion, an average of 2 months)
