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

This study has been completed.

Sponsor:

Information provided by:

Hippocration General Hospital

ClinicalTrials.gov Identifier:

NCT00892164

First received: April 30, 2009

Last updated: May 1, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

May 1, 2009

Start Date ^ICMJE

August 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hemostasis [ Time Frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
Operative time [ Time Frame: from skin incision to skin closure ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00892164 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Length of hospital stay [ Time Frame: postoperatively (from the day of surgery until discharge) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Thyroidectomy

Intervention ^ICMJE

Device: harmonic scalpel device (FOCUS)
hemostatic device utilized intraoperatively
Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
hemostatic device utilized intraoperatively

Study Arm (s)

Active Comparator: FOCUS (Group A)
Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device

Intervention: Device: harmonic scalpel device (FOCUS)
Active Comparator: LIGASURE (Group Β)
Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device

Intervention: Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

April 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT00892164

Other Study ID Numbers ^ICMJE

642

Has Data Monitoring Committee

Yes

Responsible Party

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

Study Sponsor ^ICMJE

Hippocration General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Hippocration General Hospital

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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