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Status unknownNCT03120754Updated Apr 19, 2017

Study of Abdominal Drainage in LCBDE+PC

An interventional study of Place the peritoneal drainage and No peritoneal drainage in Enhanced Recovery After Surgery, sponsored by Zhongshan Hospital Xiamen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-19.

Sponsored by Zhongshan Hospital Xiamen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Enhanced Recovery After Surgery

Keywords

  • ERAS
  • Peritoneal drainage
  • Primary Closure
03

In context

Lead sponsor

Zhongshan Hospital Xiamen University is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Placement of peritoneal drainage

    Procedure: Place the peritoneal drainage

  • Active comparator
    Control group

    No peritoneal drainage

    Procedure: No peritoneal drainage

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.

06

What researchers measure

Primary outcomes

  1. Hospital stay

    length of patient stay.

    Time frame: 3 days

Secondary outcomes

  1. Postoperative pain

    Observation on pain after operation in the two groups, were evaluated according to the standard for evaluation of VAS pain score.

    Time frame: 24 and 48hours

Other outcomes

  1. Complication

    The postoperative complications were compared, such as bile leakage, abdominal infection and so on.

    Time frame: 6 month

07

Study locations

1 of 1 sites recruiting
  • Department of hepatobiliary and pancreatic surgery; Zhongshan Hospital Affiliated to Xiamen University
    Xiamen, Fujian 361000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2017 (actual). Primary completion is estimated for Jul 2018, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2017
First posted
Apr 19, 2017
StartActual
Mar 24, 2017
Primary completionEst.
Jul 30, 2018
CompletionEst.
Dec 31, 2018
Last update
Apr 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03120754
Lead sponsor
Zhongshan Hospital Xiamen University
Responsible party
Jianyin Zhou (Chief physician, Zhongshan Hospital Xiamen University) — Principal investigator
First posted
Apr 19, 2017
Start date
Mar 24, 2017
Primary completion
Jul 30, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Apr 19, 2017

Study contacts

Zhou Jianyin
Contact
zhoujianyin2000@sina.com
+86 13606097132

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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