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Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer

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ClinicalTrials.gov Identifier: NCT00892164
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : May 4, 2009
Sponsor:
Information provided by:
Hippocration General Hospital

Brief Summary:
The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device to that with the electrothermal bipolar vessel sealer.

Condition or disease Intervention/treatment Phase
Thyroidectomy Device: harmonic scalpel device (FOCUS) Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE) Not Applicable

Detailed Description:
The harmonic scalpel and the electrothermal bipolar vessel sealing system (LIGASURE PRECISE) have been both shown to be safe and effective in thyroid surgery. The moderate dissection capabilities of the previous harmonic scalpel instruments available for thyroid surgery have led to an innovative technical improvement of the device (FOCUS) that has very recently been implemented and has been made available in 2008. Comparison of the utilization of this new device, however, with the electrothermal bipolar vessel sealer has not been performed in any study. The objective of this study is to compare the results of total thyroidectomy using the FOCUS to that with the LIGASURE device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a total thyroidectomy in our endocrine surgery department are randomized into those operated with FOCUS (Group A) and those with LIGASURE (Group B).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: FOCUS (Group A)
Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
Device: harmonic scalpel device (FOCUS)
hemostatic device utilized intraoperatively
Active Comparator: LIGASURE (Group Β)
Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device
Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
hemostatic device utilized intraoperatively



Primary Outcome Measures :
  1. Hemostasis [ Time Frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively) ]
  2. Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn [ Time Frame: postoperatively (from the day of surgery until 3-6 months postoperatively) ]
  3. Operative time [ Time Frame: from skin incision to skin closure ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: postoperatively (from the day of surgery until discharge) ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total thyroidectomy

Exclusion Criteria:

  • hemithyroidectomy or subtotal thyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892164


Locations
Greece
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens
Athens, Abelokipoi (Vas. Sofias 114 av.), Greece, 11527
Sponsors and Collaborators
Hippocration General Hospital
Investigators
Principal Investigator: Andreas Manouras, MD, PhD Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece

Responsible Party: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens
ClinicalTrials.gov Identifier: NCT00892164     History of Changes
Other Study ID Numbers: 642
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: May 4, 2009
Last Verified: May 2009

Keywords provided by Hippocration General Hospital:
thyroid surgery
total thyroidectomy
harmonic scalpel
electrothermal bipolar vessel sealer
hemostatic device

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Hemostatics
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Coagulants