Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01126060
First received: April 15, 2010
Last updated: November 15, 2011
Last verified: November 2011

April 15, 2010
November 15, 2011
February 2010
January 2011   (final data collection date for primary outcome measure)
Postoperative Drainage Amount [ Time Frame: serial measurement from 1day to 4day after surgery ] [ Designated as safety issue: No ]
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
Postoperative drain amount [ Time Frame: serial measurement from 1day to 4day after surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01126060 on ClinicalTrials.gov Archive Site
Not Provided
seroma / hematoma [ Time Frame: serial measurement from 1day to 4day after surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
Efficacy of Fibrin Sealant to Reduce the Amount of Postoperative Drain in Patients With Harmonic Scalpel-assisted Total Thyroidectomy With Anterior Compartment Neck Dissections

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Thyroid Carcinoma
  • Thyroidectomy
  • Drug: Usage of Fibrin sealant
    Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection
  • Procedure: Thyroidectomy
    surgical removal of bilateral thyroid glands
  • Active Comparator: Fibrin sealant
    usage of fibrin sealant after surgery
    Interventions:
    • Drug: Usage of Fibrin sealant
    • Procedure: Thyroidectomy
  • No Intervention: Control
    No usage of fibrin sealant
    Intervention: Procedure: Thyroidectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • proven thyroid carcinoma
  • Thyroidectomy with anterior compartment neck dissection

Exclusion Criteria:

  • No use of harmonic scalpel during surgery
  • coagulation abnormality
  • refuse to participate
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01126060
2009-12-093
Not Provided
Man Ki Chung/Assistant professor, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP