Study of Abdominal Drainage in LCBDE+PC

NCT ID: NCT03120754

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-24
• Study Completion Date: 2018-12-31

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.

Conditions

Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Placement of peritoneal drainage

Group Type: EXPERIMENTAL

Place the peritoneal drainage

Intervention Type: PROCEDURE

In the experimental group, the abdominal drainage was not placed

Control group

No peritoneal drainage

Group Type: ACTIVE_COMPARATOR

No peritoneal drainage

Intervention Type: PROCEDURE

Intraoperative placement of peritoneal drainage as control group.

Interventions

Place the peritoneal drainage

In the experimental group, the abdominal drainage was not placed

Intervention Type: PROCEDURE

No peritoneal drainage

Intraoperative placement of peritoneal drainage as control group.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Hospital Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Jianyin Zhou

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhou Jianyin

Role: CONTACT

zhoujianyin2000@sina.com

+86 13606097132

Other Identifiers

011314

Identifier Type: -

Identifier Source: org_study_id