Clinical Trial on Harmonic Focus Shears

Multinodular Goiter Clinical Trial

Official title:

Harmonic Focus Shears Versus Clamp-and-technique for Total Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003652
• Other study ID #: St Luc
• Status: Completed
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy.

Description:

According to a randomized sequence, total thyroidectomy was performed in 34 patients using Harmonic Focus and in 34 patients using clamp-and-tie technique.

In this randomized prospective trial, differences in the duration of surgery, intraoperative bleeding and post-operative complications were analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total thyroidectomy for multinodular goiter in adults patients

Exclusion Criteria:

• Redo surgery, malignancy.

Related Conditions & MeSH terms

• Goiter
• Multinodular Goiter

Intervention

Procedure:
• thyroidectomy
Comparison between two groups of patients. One group is operated on using harmonic Focus for haemostasis compared to a second group of patients operated on with the conventional haemostasis using tie-and-clamp technique

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy		day one after surgery
Secondary	Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis		during the operation