NCT00892164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
Last Updated

May 4, 2009

Status Verified

May 1, 2009

Enrollment Period

4 months

First QC Date

April 30, 2009

Last Update Submit

May 1, 2009

Conditions

Thyroidectomy

Keywords

thyroid surgerytotal thyroidectomyharmonic scalpelelectrothermal bipolar vessel sealerhemostatic device

Outcome Measures

Primary Outcomes (3)

  • Hemostasis

    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

    postoperatively (from the day of surgery until 3-6 months postoperatively)

  • Operative time

    from skin incision to skin closure

Secondary Outcomes (1)

  • Length of hospital stay

    postoperatively (from the day of surgery until discharge)

Study Arms (2)

FOCUS (Group A)

ACTIVE COMPARATOR

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

Device: harmonic scalpel device (FOCUS)

LIGASURE (Group Β)

ACTIVE COMPARATOR

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

Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

Interventions

harmonic scalpel device (FOCUS)DEVICE

hemostatic device utilized intraoperatively

FOCUS (Group A)
electrothermal bipolar vessel sealing system (LIGASURE PRECISE)DEVICE

hemostatic device utilized intraoperatively

LIGASURE (Group Β)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • total thyroidectomy

You may not qualify if:

  • hemithyroidectomy or subtotal thyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, Abelokipoi (Vas. Sofias 114 Av.), 11527, Greece

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 4, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

May 4, 2009

Record last verified: 2009-05

Locations

GR(1)