Drainage or Not for Laparoscopic Cholecystetomy

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

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.

  1. VAS
  2. Nause and vomiting
  3. infection
  4. bleeding
  5. bile leakage
  6. puncture drainage
  7. readmission
  8. reoperation
  9. hospital stay
  10. 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

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

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

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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