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

Sponsor

Yonsei University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01625247

Collaborator

(none)

162

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis Empyema	Procedure: Surgical drainage	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 arm Patients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.	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.
Active Comparator: 2 arm Patients under LC. Allocation to sham drain,	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.

Arm

Intervention/Treatment

Experimental: 1 arm

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

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.

Active Comparator: 2 arm

Patients under LC. Allocation to sham drain,

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.

Outcome Measures

Primary Outcome Measures

frequency of postoperative complication occurrence [whinin 1 week and 8 weeks postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severance hospital	Seoul		Korea, Republic of	135-720

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01625247

Other Study ID Numbers:

3-2008-0140

First Posted:

Jun 21, 2012

Last Update Posted:

Jun 21, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Empyema

Cholecystitis

Acalculous Cholecystitis

Cholecystitis, Acute

Study Results

No Results Posted as of Jun 21, 2012