Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer - Full Text View

Sponsored by:	Hippocration General Hospital
Information provided by:	Hippocration General Hospital
ClinicalTrials.gov Identifier:	NCT00892164

Purpose

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	Intervention
Thyroidectomy	Device: harmonic scalpel device (FOCUS) Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

MedlinePlus related topics: Surgery

Drug Information available for: Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study

Further study details as provided by Hippocration General Hospital:

Primary Outcome Measures:

Hemostasis [ Time Frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
Operative time [ Time Frame: from skin incision to skin closure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Length of hospital stay [ Time Frame: postoperatively (from the day of surgery until discharge) ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	August 2008
Study Completion Date:	April 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
FOCUS (Group A): Active Comparator Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device	Device: harmonic scalpel device (FOCUS) hemostatic device utilized intraoperatively
LIGASURE (Group Β): Active Comparator 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

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).

Eligibility

Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892164

Locations

Greece, Abelokipoi (Vas. Sofias 114 av.)
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

More Information

No publications provided

Responsible Party:	Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens ( Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens )
Study ID Numbers:	642
Study First Received:	April 30, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00892164 History of Changes
Health Authority:	Greece: Ethics Committee

Keywords provided by Hippocration General Hospital:

thyroid surgery
total thyroidectomy
harmonic scalpel
electrothermal bipolar vessel sealer
hemostatic device

Study placed in the following topic categories:

Hemostatics

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on May 07, 2009