Clinical trial NCT03120754: Study of Abdominal Drainage in LCBDE+PC
Official title: Clinical Study of Abdominal Drainage in Laparoscopic Common Bile Duct Exploration With Primary Closure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enhanced Recovery After Surgery
Keywords: ERAS
Peritoneal drainage
Primary Closure
Lead sponsor: Zhongshan Hospital Xiamen University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SPSS statistical analysis system by the deputy director of our department physician, accepted treatment of 80 subjects (test group and control group) randomly arranged, which lists the serial number from 1 to 80 corresponding to the treatment assignment. In the experiment, 1 patients were divided into the exper
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hospital stay
timeFrame: 3 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 and 48hours
Other outcomes:
measure: Complication
timeFrame: 6 month
Locations:
city: Xiamen City
country: China
facility: Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University
state: Fujian
Study officials:
References: