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

Yonsei University

Status and phase: Unknown; Phase 3

Conditions: Empyema; Acute Cholecystitis

Treatments: Procedure: Surgical drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01625247

3-2008-0140

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

1 arm

Experimental group

Description:

Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.

Treatment:

Procedure: Surgical drainage

2 arm

Active Comparator group

Description:

Patients under LC. Allocation to sham drain,

Treatment:

Procedure: Surgical drainage