Drainage or Not for Laparoscopic Cholecystetomy

Not Applicable

• Conditions: Cholecystitis; Cholecystolithiasis; Adenomyosis of Gallbladder; Polyps Gallbladder
• Interventions: Procedure: drainage tube

• Registration Number: NCT03909360
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-03-14
• Study First Submitted: 2019-03-17
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
drainage	drainage tube	Placement of subhepatic drainage tube for laparoscopic cholecytetomy

Primary Outcome Measures

Name	Time	Method
Puncture drainage Puncture drainage	day 1 to one month post LC operation	the percentage of puncture drainage; Puncture drainage; Puncture drainage
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
reoperation Reoperation	day 1 to one month post LC operation	the percentage of reoperation

Secondary Outcome Measures

Name	Time	Method
Hospitalization expenses	day 1 to discharge post LC operation	Hospitalization expenses
VAS score	day 1 to discharge post LC operation	VAS score
infection	day 1 to discharge post LC operation	the morbidity of infection (abdominal, incision,pulmonary,et al)
hospital stay	day 1 to discharge post LC operation	hospital stay
Nausea and vomiting	day 1 to discharge post LC operation	the morbidity of Nausea and vomiting

Trial Locations

Locations (1)

The second affiliated hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China