Adenomyosis of Gallbladder, Cholecystitis, Cholecystolithiasis, Polyps Gallbladder
Conditions
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. 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
Interventions
PROCEDUREdrainage tube
sub-hepatic drainage tube for laparoscopic cholecystectomy
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| readmission | day 1 to one month post LC operation | the percentage of readmission |
| bleeding Bile leakage | day 1 to one month post LC operation | the morbidity of bleeding the morbidity of bile leakage |
| bile leakage | day 1 to one month post LC operation | the morbidity of bile leakage |
| Puncture drainage Puncture drainage | day 1 to one month post LC operation | the percentage of puncture drainage Puncture drainage Puncture drainage |
| reoperation Reoperation | day 1 to one month post LC operation | the percentage of reoperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospital stay | day 1 to discharge post LC operation | hospital stay |
| Hospitalization expenses | day 1 to discharge post LC operation | Hospitalization expenses |
| VAS score | day 1 to discharge post LC operation | VAS score |
| Nausea and vomiting | day 1 to discharge post LC operation | the morbidity of Nausea and vomiting |
| infection | day 1 to discharge post LC operation | the morbidity of infection (abdominal, incision,pulmonary,et al) |
Countries
China
Contacts
Primary ContactHuanbing Zhu, MD
Outcome results
None listed