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临床试验/NCT03120754
NCT03120754Unknown不适用

Clinical Study of Abdominal Drainage in Laparoscopic Common Bile Duct Exploration With Primary Closure

Zhongshan Hospital Xiamen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Hospital stay

研究概览

简要总结

Common bile duct stones in clinical manifestations of biliary colic, obstructive jaundice, cholangitis, pancreatitis and other symptoms. At present, thanks to the rapid development of minimally invasive surgery and the concept of ERAS, laparoscopic common bile duct incision and primary suture has been gradually used as a routine surgical approach in clinical application. However, whether or not to place the abdominal drainage tube after surgery, so far has not yet reached a consensus. Therefore, this study focuses on the clinical advantages of LCBDE+PC placed abdominal drainage.

详细描述

On the basis of the analysis of 7 cases were selected by laparoscopic treatment of cholecystolithiasis complicated with choledocholithiasis bile duct suture in patients with a clinical data of our hospital were prospectively divided into peritoneal drainage group of 40 cases, no abdominal drainage group of 40 cases, compared two groups of operation time, hospitalization time and cost, operation cost, operation bleeding and postoperative bilirubin recovery, complication and return to hospital again and so on, and to explore the clinical significance of indwelling drainage tube.

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

入选标准

  • cholecystocholedocholithiasis or simple choledocholithiasis, no intrahepatic bile duct stones, bile duct diameter greater than 8 mm;
  • no acute suppurative cholangitis or severe acute biliary pancreatitis;
  • all patients were treated with internal medicine before operation, such as anti inflammation, liver protection, correction of anemia, hypoproteinemia, disturbance of electrolyte and acid-base imbalance;
  • there was no obvious stenosis of common bile duct;
  • aged from 18 to 80 years;
  • BMI<30 kg / m2;
  • American Society of anesthesiologists (ASA) anesthesia risk rating of 1 or 2.

排除标准

  • severe anemia or thrombocytopenia in patients with 50*109/L, PT is greater than 15s and can not correct the coagulation disorders;
  • severe heart and lung complications can not tolerate pneumoperitoneum and other laparoscopic surgery contraindications;
  • IgG4 associated cholangitis and other immune system diseases;
  • there is a serious systemic disease. The patients with the following conditions:
  • there was inflammatory stenosis or Oddi sphincter hyperemia and edema at the lower end of the common bile duct;
  • in acute inflammation in patients with obstructive jaundice, such patients have biliary dilatation, the bile duct wall edema obviously and easily with bile duct opening at the lower end of the inflammatory edema, biliary high pressure, suture of bile duct after prone to bile leakage;
  • the presence of severe cholangitis requiring emergency biliary drainage;
  • it is difficult to get a combination of intrahepatic bile duct stones and choledochoscopy;
  • Mirizzi syndrome type II-IV.

结局指标

主要结局

Hospital stay

时间窗: 3 days

length of patient stay.

次要结局

  • Postoperative pain(24 and 48hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianyin Zhou

Chief physician

Zhongshan Hospital Xiamen University

研究点 (1)

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