Drainage or Not for Laparoscopic Cholecystetomy

Cholecystitis Clinical Trial

Official title:

Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909360
• Other study ID #: zyeyLCdrainage
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Huanbing Zhu, MD
• Phone: 15857174159
• Email: juvanbn[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Adenomyosis of Gallbladder
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Polyps Gallbladder

Intervention

Procedure:
• drainage tube
sub-hepatic drainage tube for laparoscopic cholecystectomy

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding Bile leakage	the morbidity of bleeding; the morbidity of bile leakage	day 1 to one month post LC operation
Primary	bile leakage	the morbidity of bile leakage	day 1 to one month post LC operation
Primary	Puncture drainage Puncture drainage	the percentage of puncture drainage; Puncture drainage; Puncture drainage	day 1 to one month post LC operation
Primary	reoperation Reoperation	the percentage of reoperation	day 1 to one month post LC operation
Primary	readmission	the percentage of readmission	day 1 to one month post LC operation
Secondary	hospital stay	hospital stay	day 1 to discharge post LC operation
Secondary	Hospitalization expenses	Hospitalization expenses	day 1 to discharge post LC operation
Secondary	VAS score	VAS score	day 1 to discharge post LC operation
Secondary	Nausea and vomiting	the morbidity of Nausea and vomiting	day 1 to discharge post LC operation
Secondary	infection	the morbidity of infection (abdominal, incision,pulmonary,et al)	day 1 to discharge post LC operation