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NCT01625247 Clinical Trial

Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01625247
Other study ID # 3-2008-0140
Secondary ID
Status Recruiting
Phase Phase 3
First received June 12, 2012
Last updated June 20, 2012
Start date June 2009
Est. completion date December 2012

Study information
Verified date June 2012
Source Yonsei University
Contact Dong Sup Yoon, MD
Phone 82-2-2019-2444
Email yds1660@yuhs.ac
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Laparoscopic cholecystectomy (LC) is the current preferred method of cholecystectomy. The role of routine drainage after LC to decrease postoperative morbidity is still an issue of considerable debate. The goal of this study was to assess to role of drains in LC, performed for acute inflamed gallbladder.

Recruitment information / eligibility
Status Recruiting
Enrollment 162
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Acute cholecystis

- Laparoscopic cholecystectomy

- KAROFSKY PERFORMANCE SCALE > 70

- No history of major operation

Exclusion Criteria:

- NYHA class > 3

- Open cholecystectomy

- No- compliance

- Intraoperative injuries

- Inadequate hemostasis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical drainage
Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.

Locations
Country Name City State
Korea, Republic of Gangnam Severance hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of postoperative complication occurrence whinin 1 week and 8 weeks postoperatively No
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