Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
1 other identifier
interventional
78
1 country
1
Brief Summary
Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2010
Shorter than P25 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
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
December 19, 2011
CompletedDecember 19, 2011
November 1, 2011
11 months
April 15, 2010
September 6, 2011
November 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Drainage Amount
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
serial measurement from 1day to 4day after surgery
Study Arms (2)
Fibrin sealant
ACTIVE COMPARATORusage of fibrin sealant after surgery
Control
NO INTERVENTIONNo usage of fibrin sealant
Interventions
Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection
Eligibility Criteria
You may qualify if:
- proven thyroid carcinoma
- Thyroidectomy with anterior compartment neck dissection
You may not qualify if:
- No use of harmonic scalpel during surgery
- coagulation abnormality
- refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
realtive small number of patients to retrieve significant difference between two groups
Results Point of Contact
- Title
- Dr. Man Ki Chung
- Organization
- Samsung medical center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 15, 2010
First Posted
May 19, 2010
Study Start
February 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
December 19, 2011
Results First Posted
December 19, 2011
Record last verified: 2011-11