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

May 1, 2009 updated by: Hippocration General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Abelokipoi (Vas. Sofias 114 av.)
      • Athens, Abelokipoi (Vas. Sofias 114 av.), Greece, 11527
        • Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemostasis
Time Frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)
intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)
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)
postoperatively (from the day of surgery until 3-6 months postoperatively)
Operative time
Time Frame: from skin incision to skin closure
from skin incision to skin closure

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: postoperatively (from the day of surgery until discharge)
postoperatively (from the day of surgery until discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2009

Last Update Submitted That Met QC Criteria

May 1, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 642

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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