Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 21, 2012
June 1, 2012
3.5 years
June 12, 2012
June 20, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
frequency of postoperative complication occurrence
whinin 1 week and 8 weeks postoperatively
Study Arms (2)
1 arm
EXPERIMENTALPatients under LC. Allocated to drain placement . Drainage was removed if the drainage amount was less than 20cc.
2 arm
ACTIVE COMPARATORPatients under LC. Allocation to sham drain,
Interventions
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.
Eligibility Criteria
You may qualify if:
- Acute cholecystis
- Laparoscopic cholecystectomy
- KAROFSKY PERFORMANCE SCALE \> 70
- No history of major operation
You may not qualify if:
- NYHA class \> 3
- Open cholecystectomy
- No- compliance
- Intraoperative injuries
- Inadequate hemostasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gangnam Severance hospital
Seoul, Seoul, 135-720, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 21, 2012
Study Start
June 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 21, 2012
Record last verified: 2012-06