Clinical Trial on Harmonic Focus Shears

NCT ID: NCT01003652

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multinodular Goiter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Harmonic Focus /conventional haemostasis

thyroidectomy

Intervention Type 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

Harmonic Focus

No interventions assigned to this group

new surgical device

No interventions assigned to this group

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

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Total thyroidectomy for multinodular goiter in adults patients

Exclusion Criteria

* Redo surgery, malignancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Mourad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St Luc

Locations

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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St Luc

Identifier Type: -

Identifier Source: org_study_id

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