Know Cancer

forgot password

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

18 Years
85 Years
Not Enrolling
Thyroid Nodule, Goiter, Thyroiditis, Graves Disease

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Presence/absence of complications (composite score)

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Benjamin Lallemant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes


France: Committee for the Protection of Personnes

Study ID:




Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Thyroid Nodule
  • Goiter
  • Thyroiditis
  • Graves Disease
  • da vinci robot
  • Thyroidectomy
  • Goiter
  • Graves Disease
  • Thyroid Nodule
  • Thyroiditis