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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00049-32 | Other Identifier | RCB number |
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Unable to find enough patients who accept randomization of surgical procedures.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot arm | Experimental | Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique. |
|
| Open surgery | Active Comparator | Patients in this arm will have a thyroidectomy using an open surgical technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted thyroidectomy | Procedure | Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Lallemant, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | Gard | 30029 | France |
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D006042 | Goiter |
| D013966 | Thyroiditis |
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Open thyroidectomy | Procedure | Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique |
|
| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |