Back to resultsDrainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
Primary Purpose
Acute Cholecystitis, Empyema
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Surgical drainage
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- Acute cholecystis
- Laparoscopic cholecystectomy
- KAROFSKY PERFORMANCE SCALE > 70
- No history of major operation
Exclusion Criteria:
- NYHA class > 3
- Open cholecystectomy
- No- compliance
- Intraoperative injuries
- Inadequate hemostasis
Sites / Locations
- Gangnam Severance hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 arm
2 arm
Arm Description
Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
Patients under LC. Allocation to sham drain,
Outcomes
Primary Outcome Measures
frequency of postoperative complication occurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01625247
Brief Title
Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis, Empyema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 arm
Arm Type
Experimental
Arm Description
Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
Arm Title
2 arm
Arm Type
Active Comparator
Arm Description
Patients under LC. Allocation to sham drain,
Intervention Type
Procedure
Intervention Name(s)
Surgical drainage
Intervention Description
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.
Primary Outcome Measure Information:
Title
frequency of postoperative complication occurrence
Time Frame
whinin 1 week and 8 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute cholecystis
Laparoscopic cholecystectomy
KAROFSKY PERFORMANCE SCALE > 70
No history of major operation
Exclusion Criteria:
NYHA class > 3
Open cholecystectomy
No- compliance
Intraoperative injuries
Inadequate hemostasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Sup Yoon, MD
Phone
82-2-2019-2444
Email
yds1660@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Sup Yoon, MD
Phone
82-2-2019-2444
Email
yds1660@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Dong Sup Yoon, MD
12. IPD Sharing Statement
Learn more about this trial
Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
We'll reach out to this number within 24 hrs