Clinical trial NCT01320813: Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
Official title: Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thyroid Nodule
Goiter
Thyroiditis
Graves Disease
Keywords: da vinci robot
Thyroidectomy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of complications (composite score)
timeFrame: 12 months
Secondary outcomes:
measure: Incision size (mm)
timeFrame: 12 months
measure: Patient satisfaction score
timeFrame: 12 months
measure: Presence/absence of conversion to open technique
timeFrame: 1 day
measure: Operating room prep time (min)
timeFrame: 1 day
measure: Presence/absence of per-operative complications
timeFrame: 1 day
measure: Hospital stay (d)
timeFrame: 7 to 15 days post-op
measure: Change in thyroglobulinemia (ng/l)
timeFrame: 12 months
measure: Change in calcemia (mg/l)
timeFrame: Day 1
measure: Change in calcemia (mg/l)
timeFrame: Day 7 to 15
measure: Change in calcemia (mg/l)
timeFrame: 12 months
measure: Change in phosphoremia (mg/l)
timeFrame: Day 1
measure: Change in phosphoremia (mg/l)
timeFrame: Days 7 to 15
measure: Change in phosphoremia (mg/l)
timeFrame: 12 months
measure: Change in parathormonemia (ng/l)
timeFrame: Day 1
measure: Change in parathormonemia (ng/l)
timeFrame: Days 7 to 15
measure: Change in parathormonemia (ng/l)
timeFrame: 12 months
measure: Visual Analog Pain Score
timeFrame: Day 1
measure: Visual Analog Pain Score
timeFrame: Days 7 to 15
measure: Visual Analog Pain Score
timeFrame: 12 months
measure: Direct medical costs (€)
timeFrame: 12 months
measure: Indirect medical costs (€)
timeFrame: 12 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Benjamin Lallemant, MD
role: PRINCIPAL_INVESTIGATOR
References: