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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, France
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.
Time frame: 12 months
Incision size (mm)
Length of incision in the open group, and sum of incision lengths in the robot group.
Time frame: 12 months
Patient satisfaction score
Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.
Time frame: 12 months
Presence/absence of conversion to open technique
For patients in the robot arm: presence/absence of conversion to open technique.
Time frame: 1 day
Operating room prep time (min)
Time in minutes necessary to prep the operating room
Time frame: 1 day
Presence/absence of per-operative complications
Presence/absence of per-operative complications
Time frame: 1 day
Hospital stay (d)
Length of hospitalization in days required after thyroidectomy
Time frame: 7 to 15 days post-op
Change in thyroglobulinemia (ng/l)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline
Time frame: 12 months
Change in calcemia (mg/l)
Calcemia on Day 1 - Calcemia at inclusion
Time frame: Day 1
Change in calcemia (mg/l)
Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion
Time frame: Day 7 to 15
Change in calcemia (mg/l)
Calcemia at 12 months - Calcemia at inclusion
Time frame: 12 months
Change in phosphoremia (mg/l)
Phosphoremia at 1 day postop - Phosphoremia at inclusion
Time frame: Day 1
Change in phosphoremia (mg/l)
Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion
Time frame: Days 7 to 15
Change in phosphoremia (mg/l)
Phosphoremia at 12 months - Phosphoremia at inclusion
Time frame: 12 months
Change in parathormonemia (ng/l)
Parathormonemia on Day 1 post-op - parathormonemia at inclusion
Time frame: Day 1
Change in parathormonemia (ng/l)
Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion
Time frame: Days 7 to 15
Change in parathormonemia (ng/l)
Parathormonemia at 12 months - parathormonemia at inclusion
Time frame: 12 months
Visual Analog Pain Score
Visual Analog Scale for pain (0.0 to 10.0)
Time frame: Day 1
Visual Analog Pain Score
Visual Analog Scale for pain (0.0 to 10.0)
Time frame: Days 7 to 15
Visual Analog Pain Score
Visual Analog Scale for pain (0.0 to 10.0)
Time frame: 12 months
Direct medical costs (€)
Time frame: 12 months
Indirect medical costs (€)
Time frame: 12 months