Study of Abdominal Drainage in LCBDE+PC

Xiamen University

Status: Unknown

Conditions: Enhanced Recovery After Surgery

Treatments: Procedure: No peritoneal drainage; Procedure: Place the peritoneal drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT03120754

011314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Placement of peritoneal drainage

Treatment:

Procedure: Place the peritoneal drainage

Control group

Active Comparator group

Description:

No peritoneal drainage

Treatment:

Procedure: No peritoneal drainage