Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01320813
• Date of registration: 22/03/2011
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
• Scientific title: Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy
• Date of first enrolment: September 2011
• Target sample size: 5
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01320813
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Benjamin Lallemant, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Thyroiditis

Graves Disease

Thyroid Nodule

Goiter

Intervention(s)

Procedure: Robot-assisted thyroidectomy

Procedure: Open thyroidectomy

Primary Outcome(s)

Presence/absence of complications (composite score) [Time Frame: 12 months]

Secondary Outcome(s)

Change in calcemia (mg/l) [Time Frame: Day 1]

Change in calcemia (mg/l) [Time Frame: Day 7 to 15]

Change in parathormonemia (ng/l) [Time Frame: Days 7 to 15]

Change in parathormonemia (ng/l) [Time Frame: Day 1]

Operating room prep time (min) [Time Frame: 1 day]

Change in calcemia (mg/l) [Time Frame: 12 months]

Change in phosphoremia (mg/l) [Time Frame: Days 7 to 15]

Change in phosphoremia (mg/l) [Time Frame: Day 1]

Change in thyroglobulinemia (ng/l) [Time Frame: 12 months]

Direct medical costs (€) [Time Frame: 12 months]

Indirect medical costs (€) [Time Frame: 12 months]

Incision size (mm) [Time Frame: 12 months]

Presence/absence of conversion to open technique [Time Frame: 1 day]

Visual Analog Pain Score [Time Frame: 12 months]

Patient satisfaction score [Time Frame: 12 months]

Change in phosphoremia (mg/l) [Time Frame: 12 months]

Visual Analog Pain Score [Time Frame: Days 7 to 15]

Change in parathormonemia (ng/l) [Time Frame: 12 months]

Hospital stay (d) [Time Frame: 7 to 15 days post-op]

Presence/absence of per-operative complications [Time Frame: 1 day]

Visual Analog Pain Score [Time Frame: Day 1]

Secondary ID(s)

2011-A00049-32

PHRC-I/2010/BL-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors