Study of Abdominal Drainage in LCBDE+PC

NCT03120754 | Unknown DMC

• 1 other identifier: 011314
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery

Keywords

ERAS; Peritoneal drainage; Primary Closure

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  length of patient stay.

  3 days

Secondary Outcomes (1)

• Postoperative pain

  24 and 48hours

Other Outcomes (1)

• Complication

  6 month

Study Arms (2)

Experimental Group

EXPERIMENTAL

Placement of peritoneal drainage

Procedure: Place the peritoneal drainage

Control group

ACTIVE COMPARATOR

No peritoneal drainage

Procedure: No peritoneal drainage

Interventions

Place the peritoneal drainage PROCEDURE

In the experimental group, the abdominal drainage was not placed

Experimental Group

No peritoneal drainage PROCEDURE

Intraoperative placement of peritoneal drainage as control group.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

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

Xiamen, Fujian, 361000, China

RECRUITING

Central Study Contacts

Zhou Jianyin

CONTACT

+86 13606097132; zhoujianyin2000@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: SPSS statistical analysis system by the deputy director of our department physician, accepted treatment of 80 subjects (test group and control group) randomly arranged, which lists the serial number from 1 to 80 corresponding to the treatment assignment. In the experiment, 1 patients were divided into the exper

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 19, 2017
• Study Start: March 24, 2017
• Primary Completion: July 30, 2018
• Study Completion: December 31, 2018
• Last Updated: April 19, 2017

Record last verified: 2017-03

Locations

CN (1)