NCT01649154

Brief Summary

The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.

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 Apr 2011

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

April 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
Last Updated

July 25, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 24, 2012

Last Update Submit

July 20, 2012

Conditions

Benign Thoroid Disease Requiring Total Thyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.

Secondary Outcomes (1)

  • Cost assessment of new generation devices in thyroid surgery

Study Arms (3)

Ligasure Small-JAW

ACTIVE COMPARATOR
Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Harmonic Focus

ACTIVE COMPARATOR
Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Clamp-and-Tie technique

ACTIVE COMPARATOR
Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Interventions

Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic FocusPROCEDURE
Clamp-and-Tie techniqueHarmonic FocusLigasure Small-JAW

Eligibility Criteria

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

You may qualify if:

  • thyroid benign disease

You may not qualify if:

  • malignant disease
  • thyroid malign disease requiring lymphadenectomy
  • coagulatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regina Apostolorum

Albano Laziale, Rome, 00041, Italy

Location

MeSH Terms

Interventions

Cytidine Diphosphate

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2012

First Posted

July 25, 2012

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

July 25, 2012

Record last verified: 2012-06

Locations

IT(1)