Goiter, Graves Disease, Thyroiditis, Thyroid Nodule
Conditions
Keywords
da vinci robot, Thyroidectomy
Brief summary
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.
Interventions
PROCEDURERobot-assisted thyroidectomy
Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
PROCEDUREOpen thyroidectomy
Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of complications (composite score) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | 12 months | Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0. |
| Presence/absence of conversion to open technique | 1 day | For patients in the robot arm: presence/absence of conversion to open technique. |
| Operating room prep time (min) | 1 day | Time in minutes necessary to prep the operating room |
| Presence/absence of per-operative complications | 1 day | Presence/absence of per-operative complications |
| Hospital stay (d) | 7 to 15 days post-op | Length of hospitalization in days required after thyroidectomy |
| Change in thyroglobulinemia (ng/l) | 12 months | Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline |
| Incision size (mm) | 12 months | Length of incision in the open group, and sum of incision lengths in the robot group. |
| Change in phosphoremia (mg/l) | Day 1 | Phosphoremia at 1 day postop - Phosphoremia at inclusion |
| Change in parathormonemia (ng/l) | Day 1 | Parathormonemia on Day 1 post-op - parathormonemia at inclusion |
| Visual Analog Pain Score | Day 1 | Visual Analog Scale for pain (0.0 to 10.0) |
| Direct medical costs (€) | 12 months | — |
| Indirect medical costs (€) | 12 months | — |
| Change in calcemia (mg/l) | Day 1 | Calcemia on Day 1 - Calcemia at inclusion |
Countries
France
Outcome results
None listed