Drainage or Not for Laparoscopic Cholecystetomy
Primary Purpose
Cholecystitis, Cholecystolithiasis, Polyps Gallbladder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
drainage tube
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- age:18-75 years old
- indicated and planed to receive laparoscopic cholecystectomy
Exclusion Criteria:
- cirrohosis Child Grading B and C
- upper abdominal surgery history
- adjustment of surgical name intraoperative
Sites / Locations
- The second affiliated hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
drainage
no drainage
Arm Description
Placement of subhepatic drainage tube for laparoscopic cholecytetomy
no placement of subhepatic drainage tube for laparoscopic cholecytetomy
Outcomes
Primary Outcome Measures
bleeding Bile leakage
the morbidity of bleeding
the morbidity of bile leakage
bile leakage
the morbidity of bile leakage
Puncture drainage Puncture drainage
the percentage of puncture drainage
Puncture drainage
Puncture drainage
reoperation Reoperation
the percentage of reoperation
readmission
the percentage of readmission
Secondary Outcome Measures
hospital stay
hospital stay
Hospitalization expenses
Hospitalization expenses
VAS score
VAS score
Nausea and vomiting
the morbidity of Nausea and vomiting
infection
the morbidity of infection (abdominal, incision,pulmonary,et al)
Full Information
NCT ID
NCT03909360
First Posted
March 17, 2019
Last Updated
April 12, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03909360
Brief Title
Drainage or Not for Laparoscopic Cholecystetomy
Official Title
Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Detailed Description
The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.
Compare complications as below betwwen drainage and no drainage groups.
VAS
Nause and vomiting
infection
bleeding
bile leakage
puncture drainage
readmission
reoperation
hospital stay
hospital expense
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Cholecystolithiasis, Polyps Gallbladder, Adenomyosis of Gallbladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drainage
Arm Type
Experimental
Arm Description
Placement of subhepatic drainage tube for laparoscopic cholecytetomy
Arm Title
no drainage
Arm Type
No Intervention
Arm Description
no placement of subhepatic drainage tube for laparoscopic cholecytetomy
Intervention Type
Procedure
Intervention Name(s)
drainage tube
Intervention Description
sub-hepatic drainage tube for laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
bleeding Bile leakage
Description
the morbidity of bleeding
the morbidity of bile leakage
Time Frame
day 1 to one month post LC operation
Title
bile leakage
Description
the morbidity of bile leakage
Time Frame
day 1 to one month post LC operation
Title
Puncture drainage Puncture drainage
Description
the percentage of puncture drainage
Puncture drainage
Puncture drainage
Time Frame
day 1 to one month post LC operation
Title
reoperation Reoperation
Description
the percentage of reoperation
Time Frame
day 1 to one month post LC operation
Title
readmission
Description
the percentage of readmission
Time Frame
day 1 to one month post LC operation
Secondary Outcome Measure Information:
Title
hospital stay
Description
hospital stay
Time Frame
day 1 to discharge post LC operation
Title
Hospitalization expenses
Description
Hospitalization expenses
Time Frame
day 1 to discharge post LC operation
Title
VAS score
Description
VAS score
Time Frame
day 1 to discharge post LC operation
Title
Nausea and vomiting
Description
the morbidity of Nausea and vomiting
Time Frame
day 1 to discharge post LC operation
Title
infection
Description
the morbidity of infection (abdominal, incision,pulmonary,et al)
Time Frame
day 1 to discharge post LC operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age:18-75 years old
indicated and planed to receive laparoscopic cholecystectomy
Exclusion Criteria:
cirrohosis Child Grading B and C
upper abdominal surgery history
adjustment of surgical name intraoperative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huanbing Zhu, MD
Phone
15857174159
Email
juvanbn@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiangtao Li, MD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huanbing Zhu
Phone
15857174159
Email
juvanbn@msn.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Drainage or Not for Laparoscopic Cholecystetomy
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