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Study of Abdominal Drainage in LCBDE+PC

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03120754
Enrollment
80
Registered
2017-04-19
Start date
2017-03-24
Completion date
2018-12-31
Last updated
2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Recovery After Surgery

Keywords

ERAS, Peritoneal drainage, Primary Closure

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.

Interventions

PROCEDUREPlace the peritoneal drainage

In the experimental group, the abdominal drainage was not placed

PROCEDURENo peritoneal drainage

Intraoperative placement of peritoneal drainage as control group.

Sponsors

Zhongshan Hospital Xiamen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital stay3 dayslength of patient stay.

Secondary

MeasureTime frameDescription
Postoperative pain24 and 48hoursObservation on pain after operation in the two groups, were evaluated according to the standard for evaluation of VAS pain score.

Other

MeasureTime frameDescription
Complication6 monthThe postoperative complications were compared, such as bile leakage, abdominal infection and so on.

Countries

China

Contacts

Primary ContactZhou Jianyin
zhoujianyin2000@sina.com+86 13606097132

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026