Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

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

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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The main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.

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Detailed Description

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Conditions

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Thyroid Nodule Goiter Thyroiditis Graves Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot arm

Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.

Group Type EXPERIMENTAL

Robot-assisted thyroidectomy

Intervention Type PROCEDURE

Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.

Open surgery

Patients in this arm will have a thyroidectomy using an open surgical technique.

Group Type ACTIVE_COMPARATOR

Open thyroidectomy

Intervention Type PROCEDURE

Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique

Interventions

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Robot-assisted thyroidectomy

Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.

Intervention Type PROCEDURE

Open thyroidectomy

Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease
* Patient has calcitoninemia \< 9 ng/pl
* Patient has normal calcemia
* Patient has PTH level between 5 ng/l and 75 ng/l
* The subject has a normal laryngeal mobility

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient is not available for 12 months of follow-up
* Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node
* Lymph node metastasis strongly suspected clinically and/or sonographically
* The subject has an extension of substernal thyroid (diving goiter)
* Family history of medullary thyroid cancer
* The subject has a history of neck surgery
* Contraindication for general anesthesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No