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

Primary Purpose

Thyroidectomy

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
harmonic scalpel device utilized intraoperatively
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

Eligibility Criteria

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

Inclusion Criteria:

  • total thyroidectomy

Exclusion Criteria:

  • hemithyroidectomy
  • 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, Hippocratio 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)

HARMONIC ACE (group B)

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 HARMONIC ACE harmonic scalpel 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
November 3, 2008
Last Updated
November 3, 2008
Sponsor
Hippocration General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00784407
Brief Title
Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
Official Title
Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
October 2008 (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 (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).
Detailed Description
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).

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (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
HARMONIC ACE (group B)
Arm Type
Active Comparator
Arm Description
Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device
Intervention Type
Device
Intervention Name(s)
harmonic scalpel device utilized intraoperatively
Intervention Description
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)
Primary Outcome Measure Information:
Title
Hemostasis
Time Frame
intraoperatively & postoperatively
Title
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Time Frame
postoperatively
Title
Operative time
Time Frame
from skin incision to skin closure
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: total thyroidectomy Exclusion Criteria: hemithyroidectomy 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, PhD
Organizational Affiliation
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio 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, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens
City
Athens
State/Province
Abelokipoi (Q. Sofias 114 av.)
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

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

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