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

This study has been completed.
Sponsor:
Information provided by:
Hippocration General Hospital
ClinicalTrials.gov Identifier:
NCT00784407
First received: November 3, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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).


Condition Intervention
Thyroidectomy
Device: harmonic scalpel device utilized intraoperatively

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Hippocration General Hospital:

Primary Outcome Measures:
  • Hemostasis [ Time Frame: intraoperatively & postoperatively ] [ Designated as safety issue: Yes ]
  • Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn [ Time Frame: postoperatively ] [ Designated as safety issue: Yes ]
  • Operative time [ Time Frame: from skin incision to skin closure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: postoperatively ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2008
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FOCUS (group A)
Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
Device: harmonic scalpel device utilized intraoperatively
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)
Active Comparator: HARMONIC ACE (group B)
Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device
Device: harmonic scalpel device utilized intraoperatively
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total thyroidectomy

Exclusion Criteria:

  • hemithyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784407

Locations
Greece
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.), Greece, 11527
Sponsors and Collaborators
Hippocration General Hospital
Investigators
Principal Investigator: Andreas Manouras, PhD Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
  More Information

No publications provided

Responsible Party: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens
ClinicalTrials.gov Identifier: NCT00784407     History of Changes
Other Study ID Numbers: 18858
Study First Received: November 3, 2008
Last Updated: November 3, 2008
Health Authority: Greece: Ethics Committee

Keywords provided by Hippocration General Hospital:
thyroid surgery
total thyroidectomy
harmonic scalpel

ClinicalTrials.gov processed this record on September 22, 2014