Clinical trial NCT00892164: Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer
Official title: Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Keywords: thyroid surgery
total thyroidectomy
harmonic scalpel
electrothermal bipolar vessel sealer
hemostatic device
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2009-05-04
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Hemostasis
timeFrame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)
measure: Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
timeFrame: postoperatively (from the day of surgery until 3-6 months postoperatively)
measure: Operative time
timeFrame: from skin incision to skin closure
Secondary outcomes:
measure: Length of hospital stay
timeFrame: postoperatively (from the day of surgery until discharge)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens
state: Abelokipoi (Vas. Sofias 114 av.)
Study officials:
affiliation: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
name: Andreas Manouras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: