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Completed

NCT Number: NCT00784407

Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

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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, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens

Athens, Abelokipoi (Q. Sofias 114 Av.), 11527, Greece

About this study

Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).

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

Treatment and study plan

harmonic scalpel device utilized intraoperatively

Device

harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)

Primary outcomes

  1. Hemostasis

    Time frame: intraoperatively & postoperatively

  2. Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn

    Time frame: postoperatively

  3. Operative time

    Time frame: from skin incision to skin closure

Secondary outcomes

  1. Length of hospital stay

    Time frame: postoperatively

Sponsors and collaborators

Lead sponsor

Hippocration General Hospital

Other

Registry information

Important dates

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

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.

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