Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Robot arm Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique. |
Procedure: Robot-assisted thyroidectomy
Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
|
| Active Comparator: Open surgery Patients in this arm will have a thyroidectomy using an open surgical technique. |
Procedure: Open thyroidectomy
Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Incision size (mm) [12 months]
Length of incision in the open group, and sum of incision lengths in the robot group.
- 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
- Change in calcemia (mg/l) [Day 1]
Calcemia on Day 1 - Calcemia at inclusion
- Change in calcemia (mg/l) [Day 7 to 15]
Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion
- Change in calcemia (mg/l) [12 months]
Calcemia at 12 months - Calcemia at inclusion
- Change in phosphoremia (mg/l) [Day 1]
Phosphoremia at 1 day postop - Phosphoremia at inclusion
- Change in phosphoremia (mg/l) [Days 7 to 15]
Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion
- Change in phosphoremia (mg/l) [12 months]
Phosphoremia at 12 months - Phosphoremia at inclusion
- Change in parathormonemia (ng/l) [Day 1]
Parathormonemia on Day 1 post-op - parathormonemia at inclusion
- Change in parathormonemia (ng/l) [Days 7 to 15]
Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion
- Change in parathormonemia (ng/l) [12 months]
Parathormonemia at 12 months - parathormonemia at inclusion
- Visual Analog Pain Score [Day 1]
Visual Analog Scale for pain (0.0 to 10.0)
- Visual Analog Pain Score [Days 7 to 15]
Visual Analog Scale for pain (0.0 to 10.0)
- Visual Analog Pain Score [12 months]
Visual Analog Scale for pain (0.0 to 10.0)
- Direct medical costs (€) [12 months]
- Indirect medical costs (€) [12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The patient must have given his/her informed and signed consent
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The patient must be insured or beneficiary of a health insurance plan
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The patient is available for 12 months of follow-up
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The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease
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Patient has calcitoninemia < 9 ng/pl
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Patient has normal calcemia
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Patient has PTH level between 5 ng/l and 75 ng/l
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The subject has a normal laryngeal mobility
Exclusion Criteria:
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The patient is participating in another study
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The patient is in an exclusion period determined by a previous study
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The patient is under judicial protection, under tutorship or curatorship
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The patient refuses to sign the consent
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It is impossible to correctly inform the patient
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The patient is pregnant
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The patient is breastfeeding
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The patient is not available for 12 months of follow-up
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Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node
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Lymph node metastasis strongly suspected clinically and/or sonographically
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The subject has an extension of substernal thyroid (diving goiter)
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Family history of medullary thyroid cancer
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The subject has a history of neck surgery
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Contraindication for general anesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 | Gard | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Benjamin Lallemant, MD, Centre Hospitalier Universitaire de Nîmes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHRC-I/2010/BL-01
- 2011-A00049-32