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Drainage or Not for Laparoscopic Cholecystetomy

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Cholecystitis
Adenomyosis of Gallbladder
Cholecystolithiasis
Polyps Gallbladder

Treatments

Procedure: drainage tube

Study type

Interventional

Funder types

Other

Identifiers

NCT03909360
zyeyLCdrainage

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups

drainage
Experimental group
Description:
Placement of subhepatic drainage tube for laparoscopic cholecytetomy
Treatment:
Procedure: drainage tube
no drainage
No Intervention group
Description:
no placement of subhepatic drainage tube for laparoscopic cholecytetomy

Trial contacts and locations

1

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Central trial contact

Huanbing Zhu, MD

Data sourced from clinicaltrials.gov

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