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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmonic Focus /conventional haemostasis |
| ||
| Harmonic Focus | |||
| new surgical device | |||
| Harmonic Focus / conventional haemostasis | Harmonic Focus group refers to the use of ultracision shears for haemostasis and conventional haemostasis group refers to the tie-and-clamp technique in total thyroidectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy | day one after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis | during the operation |
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Inclusion Criteria:
Exclusion Criteria:
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68 patients candidate to total thyroidectomy for multinodular goiter in an academic hospital
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| Name | Affiliation | Role |
|---|---|---|
| Michel Mourad, MD, PhD | St Luc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D006042 | Goiter |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013965 | Thyroidectomy |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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