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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
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 17, 2019
Last Updated
April 12, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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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

Learn more about this trial

Drainage or Not for Laparoscopic Cholecystetomy

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