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Completed

NCT Number: NCT01003652

Clinical Trial on Harmonic Focus Shears

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.

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Key information

Conditions

Multinodular Goiter Endocrine System Diseases Goiter Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Total thyroidectomy for multinodular goiter in adults patients

Exclusion criteria

  • Redo surgery, malignancy.

Treatment and study plan

Thyroidectomy

Procedure

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

Primary outcomes

  1. Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy

    Time frame: day one after surgery

Secondary outcomes

  1. Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis

    Time frame: during the operation

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 29, 2009
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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