Study of Abdominal Drainage in LCBDE+PC

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

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.

Study Overview

• Status: Unknown
• Conditions: Enhanced Recovery After Surgery
• Intervention / Treatment: Procedure: Place the peritoneal drainage; Procedure: No peritoneal 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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhou Jianyin; Phone Number: +86 13606097132; Email: zhoujianyin2000@sina.com

Study Locations

• China
  • Fujian
    • Xiamen City, Fujian, China, 361000
      • Recruiting
      • Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; Placement of peritoneal drainage	Procedure: Place the peritoneal drainage; In the experimental group, the abdominal drainage was not placed
ACTIVE_COMPARATOR: Control group; No peritoneal drainage	Procedure: No peritoneal drainage; Intraoperative placement of peritoneal drainage as control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	length of patient stay.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	The postoperative complications were compared, such as bile leakage, abdominal infection and so on.	6 month

Collaborators and Investigators

• Sponsor: Zhongshan Hospital Xiamen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2017
• Primary Completion (ANTICIPATED): July 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 15, 2017
• First Posted (ACTUAL): April 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: ERAS; Peritoneal drainage; Primary Closure
• Other Study ID Numbers: 011314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No