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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Thyroid Nodule; Thyroiditis; Graves Disease; Goiter

Treatments: Procedure: Open thyroidectomy; Procedure: Robot-assisted thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01320813

2011-A00049-32 (Other Identifier)

PHRC-I/2010/BL-01

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Robot arm

Experimental group

Description:

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

Treatment:

Procedure: Robot-assisted thyroidectomy

Open surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Open thyroidectomy