Study of Abdominal Drainage in LCBDE+PC

Not Applicable

• Conditions: Enhanced Recovery After Surgery
• Interventions: Procedure: Place the peritoneal drainage; Procedure: No peritoneal drainage

• Registration Number: NCT03120754
• Lead Sponsor: Zhongshan Hospital Xiamen University

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.

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-24
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-15
• Last Update Submitted: 2017-04-15
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19
• Primary Completion: 2018-07-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Place the peritoneal drainage	Placement of peritoneal drainage
Control group	No peritoneal drainage	No peritoneal drainage

Primary Outcome Measures

Name	Time	Method
Hospital stay	3 days	length of patient stay.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24 and 48hours	Observation on pain after operation in the two groups, were evaluated according to the standard for evaluation of VAS pain score.

Trial Locations

Locations (1)

Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University; 🇨🇳 Xiamen City, Fujian, China