- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909360
Drainage or Not for Laparoscopic Cholecystetomy
April 12, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huanbing Zhu, MD
- Phone Number: 15857174159
- Email: juvanbn@msn.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Huanbing Zhu
- Phone Number: 15857174159
- Email: juvanbn@msn.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: drainage
Placement of subhepatic drainage tube for laparoscopic cholecytetomy
|
sub-hepatic drainage tube for laparoscopic cholecystectomy
|
No Intervention: no drainage
no placement of subhepatic drainage tube for laparoscopic cholecytetomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bleeding Bile leakage
Time Frame: day 1 to one month post LC operation
|
the morbidity of bleeding the morbidity of bile leakage |
day 1 to one month post LC operation
|
bile leakage
Time Frame: day 1 to one month post LC operation
|
the morbidity of bile leakage
|
day 1 to one month post LC operation
|
Puncture drainage Puncture drainage
Time Frame: day 1 to one month post LC operation
|
the percentage of puncture drainage Puncture drainage Puncture drainage |
day 1 to one month post LC operation
|
reoperation Reoperation
Time Frame: day 1 to one month post LC operation
|
the percentage of reoperation
|
day 1 to one month post LC operation
|
readmission
Time Frame: day 1 to one month post LC operation
|
the percentage of readmission
|
day 1 to one month post LC operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hospital stay
Time Frame: day 1 to discharge post LC operation
|
hospital stay
|
day 1 to discharge post LC operation
|
Hospitalization expenses
Time Frame: day 1 to discharge post LC operation
|
Hospitalization expenses
|
day 1 to discharge post LC operation
|
VAS score
Time Frame: day 1 to discharge post LC operation
|
VAS score
|
day 1 to discharge post LC operation
|
Nausea and vomiting
Time Frame: day 1 to discharge post LC operation
|
the morbidity of Nausea and vomiting
|
day 1 to discharge post LC operation
|
infection
Time Frame: day 1 to discharge post LC operation
|
the morbidity of infection (abdominal, incision,pulmonary,et al)
|
day 1 to discharge post LC operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jiangtao Li, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2019
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
March 17, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zyeyLCdrainage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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