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

Primary Purpose

Thyroidectomy

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
harmonic scalpel device (FOCUS)
electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
Sponsored by
Hippocration General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroidectomy focused on measuring thyroid surgery, total thyroidectomy, harmonic scalpel, electrothermal bipolar vessel sealer, hemostatic device

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

FOCUS (Group A)

LIGASURE (Group Β)

Arm Description

Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device

Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device

Outcomes

Primary Outcome Measures

Hemostasis
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Operative time

Secondary Outcome Measures

Length of hospital stay

Full Information

First Posted
April 30, 2009
Last Updated
May 1, 2009
Sponsor
Hippocration General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00892164
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hippocration General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy
Keywords
thyroid surgery, total thyroidectomy, harmonic scalpel, electrothermal bipolar vessel sealer, hemostatic device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FOCUS (Group A)
Arm Type
Active Comparator
Arm Description
Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
Arm Title
LIGASURE (Group Β)
Arm Type
Active Comparator
Arm Description
Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device
Intervention Type
Device
Intervention Name(s)
harmonic scalpel device (FOCUS)
Intervention Description
hemostatic device utilized intraoperatively
Intervention Type
Device
Intervention Name(s)
electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
Intervention Description
hemostatic device utilized intraoperatively
Primary Outcome Measure Information:
Title
Hemostasis
Time Frame
intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)
Title
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)
Title
Operative time
Time Frame
from skin incision to skin closure
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
postoperatively (from the day of surgery until discharge)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Manouras, MD, PhD
Organizational Affiliation
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens
City
Athens
State/Province
Abelokipoi (Vas. Sofias 114 av.)
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

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

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