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

Study Overview
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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.

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

Conditions
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Thyroid Nodule, Goiter, Thyroiditis, Graves Disease

Intervention / Treatment
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* Procedure: Robot-assisted thyroidectomy
* Procedure: Open thyroidectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot arm<br>Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique. | Procedure: Robot-assisted thyroidectomy<br>* Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.<br>|
| Active Comparator: Open surgery<br>Patients in this arm will have a thyroidectomy using an open surgical technique. | Procedure: Open thyroidectomy<br>* Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of complications (composite score) | The per or post-operative occurrence of at least one of the following: postoperative hemorrhage requiring reintervention; cervical infection requiring antibiotics and/or surgical intervention; transient or persistent laryngeal paralysis; transient or persistent hypoparathyroidy (calcemia < 1.9 µmol/l). Transiient means < than and persistent means >= 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision size (mm) | Length of incision in the open group, and sum of incision lengths in the robot group. | 12 months | 
| Patient satisfaction score | Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0. | 12 months | 
| Presence/absence of conversion to open technique | For patients in the robot arm: presence/absence of conversion to open technique. | 1 day | 
| Operating room prep time (min) | Time in minutes necessary to prep the operating room | 1 day | 
| Presence/absence of per-operative complications | Presence/absence of per-operative complications | 1 day | 
| Hospital stay (d) | Length of hospitalization in days required after thyroidectomy | 7 to 15 days post-op | 
| Change in thyroglobulinemia (ng/l) | Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline | 12 months | 
| Change in calcemia (mg/l) | Calcemia on Day 1 - Calcemia at inclusion | Day 1 | 
| Change in calcemia (mg/l) | Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion | Day 7 to 15 | 
| Change in calcemia (mg/l) | Calcemia at 12 months - Calcemia at inclusion | 12 months | 
| Change in phosphoremia (mg/l) | Phosphoremia at 1 day postop - Phosphoremia at inclusion | Day 1 | 
| Change in phosphoremia (mg/l) | Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion | Days 7 to 15 | 
| Change in phosphoremia (mg/l) | Phosphoremia at 12 months - Phosphoremia at inclusion | 12 months | 
| Change in parathormonemia (ng/l) | Parathormonemia on Day 1 post-op - parathormonemia at inclusion | Day 1 | 
| Change in parathormonemia (ng/l) | Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion | Days 7 to 15 | 
| Change in parathormonemia (ng/l) | Parathormonemia at 12 months - parathormonemia at inclusion | 12 months | 
| Visual Analog Pain Score | Visual Analog Scale for pain (0.0 to 10.0) | Day 1 | 
| Visual Analog Pain Score | Visual Analog Scale for pain (0.0 to 10.0) | Days 7 to 15 | 
| Visual Analog Pain Score | Visual Analog Scale for pain (0.0 to 10.0) | 12 months | 
| Direct medical costs (€) |  | 12 months | 
| Indirect medical costs (€) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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da vinci robot, Thyroidectomy