Study of Abdominal Drainage in LCBDE+PC

Enhanced Recovery After Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03120754
• Other study ID #: 011314
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2017
• Last updated: April 15, 2017
• Start date: March 24, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2017
• Source: Zhongshan Hospital Xiamen University
• Contact: Zhou Jianyin
• Phone: +86 13606097132
• Email: zhoujianyin2000[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery

Intervention

Procedure:
• Place the peritoneal drainage
In the experimental group, the abdominal drainage was not placed
• No peritoneal drainage
Intraoperative placement of peritoneal drainage as control group.

Locations

Country	Name	City	State
China	Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University	Xiamen City	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication	The postoperative complications were compared, such as bile leakage, abdominal infection and so on.	6 month
Primary	Hospital stay	length of patient stay.	3 days
Secondary	Postoperative pain	Observation on pain after operation in the two groups, were evaluated according to the standard for evaluation of VAS pain score.	24 and 48hours