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

NCT ID: NCT01625247

Last Updated: 2012-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Cholecystitis Empyema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 arm

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

Group Type EXPERIMENTAL

Surgical drainage

Intervention Type PROCEDURE

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.

2 arm

Patients under LC. Allocation to sham drain,

Group Type ACTIVE_COMPARATOR

Surgical drainage

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gangnam Severance hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Sup Yoon, MD

Role: CONTACT

82-2-2019-2444

Facility Contacts

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Dong Sup Yoon, MD

Role: primary

82-2-2019-2444

Other Identifiers

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3-2008-0140

Identifier Type: -

Identifier Source: org_study_id

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