Skip to main content
OpenTrials
Completed

NCT Number: NCT00892164

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroidectomy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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.), 11527, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

harmonic scalpel device (FOCUS)

Device

hemostatic device utilized intraoperatively

electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

Device

hemostatic device utilized intraoperatively

Primary outcomes

  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 outcomes

  1. Length of hospital stay

    Time frame: postoperatively (from the day of surgery until discharge)

Sponsors and collaborators

Lead sponsor

Hippocration General Hospital

Other

Registry information

Official study title

Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 4, 2009
Registry last updated
May 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.