An interventional study of Robot-assisted thyroidectomy and Open thyroidectomy in Thyroid Nodule, Goiter and Thyroiditis, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 5 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.
Procedure: Robot-assisted thyroidectomy
Patients in this arm will have a thyroidectomy using an open surgical technique.
Procedure: Open thyroidectomy
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
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)
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
The record gives a start of Sep 2011, a primary completion of Sep 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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