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Clinical Trial on Harmonic Focus Shears

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ClinicalTrials.gov Identifier: NCT01003652
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Condition or disease Intervention/treatment
Multinodular Goiter Procedure: thyroidectomy

Detailed 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.


Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Clinical Trial on Harmonic Focus Shears Versus Clamp-and-technique for Total Thyroidectomy
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Group/Cohort Intervention/treatment
Harmonic Focus /conventional haemostasis 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

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



Primary Outcome Measures :
  1. Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy [ Time Frame: day one after surgery ]

Secondary Outcome Measures :
  1. Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis [ Time Frame: during the operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
68 patients candidate to total thyroidectomy for multinodular goiter in an academic hospital
Criteria

Inclusion Criteria:

  • Total thyroidectomy for multinodular goiter in adults patients

Exclusion Criteria:

  • Redo surgery, malignancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003652


Locations
Belgium
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Michel Mourad, MD, PhD St Luc

Responsible Party: Prof Michel Mourad, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01003652     History of Changes
Other Study ID Numbers: St Luc
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
goiter

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases
Hemostatics
Coagulants