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Drainage or Not for Laparoscopic Cholecystetomy

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ClinicalTrials.gov Identifier: NCT03909360
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Cholecystitis Cholecystolithiasis Polyps Gallbladder Adenomyosis of Gallbladder Procedure: drainage tube Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: drainage
Placement of subhepatic drainage tube for laparoscopic cholecytetomy
Procedure: drainage tube
sub-hepatic drainage tube for laparoscopic cholecystectomy

No Intervention: no drainage
no placement of subhepatic drainage tube for laparoscopic cholecytetomy



Primary Outcome Measures :
  1. bleeding Bile leakage [ Time Frame: day 1 to one month post LC operation ]

    the morbidity of bleeding

    the morbidity of bile leakage


  2. bile leakage [ Time Frame: day 1 to one month post LC operation ]
    the morbidity of bile leakage

  3. Puncture drainage Puncture drainage [ Time Frame: day 1 to one month post LC operation ]

    the percentage of puncture drainage

    Puncture drainage

    Puncture drainage


  4. reoperation Reoperation [ Time Frame: day 1 to one month post LC operation ]
    the percentage of reoperation

  5. readmission [ Time Frame: day 1 to one month post LC operation ]
    the percentage of readmission


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: day 1 to discharge post LC operation ]
    hospital stay

  2. Hospitalization expenses [ Time Frame: day 1 to discharge post LC operation ]
    Hospitalization expenses

  3. VAS score [ Time Frame: day 1 to discharge post LC operation ]
    VAS score

  4. Nausea and vomiting [ Time Frame: day 1 to discharge post LC operation ]
    the morbidity of Nausea and vomiting

  5. infection [ Time Frame: day 1 to discharge post LC operation ]
    the morbidity of infection (abdominal, incision,pulmonary,et al)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909360


Contacts
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Contact: Huanbing Zhu, MD 15857174159 juvanbn@msn.com

Locations
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China, Zhejiang
The second affiliated hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Huanbing Zhu    15857174159    juvanbn@msn.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Jiangtao Li, MD Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03909360     History of Changes
Other Study ID Numbers: zyeyLCdrainage
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Adenomyosis
Cholecystolithiasis
Cholelithiasis
Gallstones
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Uterine Diseases
Genital Diseases, Female
Calculi
Pathological Conditions, Anatomical