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

This study has been terminated.
(Unable to find enough patients who accept randomization of surgical procedures.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01320813
First received: March 22, 2011
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Thyroid Nodule
Goiter
Thyroiditis
Graves Disease
 Procedure: Robot-assisted thyroidectomy
Procedure: Open thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of complications (composite score) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Incision size (mm) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Length of incision in the open group, and sum of incision lengths in the robot group.

  • Patient satisfaction score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.

  • Presence/absence of conversion to open technique [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    For patients in the robot arm: presence/absence of conversion to open technique.

  • Operating room prep time (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Time in minutes necessary to prep the operating room

  • Presence/absence of per-operative complications [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Presence/absence of per-operative complications

  • Hospital stay (d) [ Time Frame: 7 to 15 days post-op ] [ Designated as safety issue: No ]
    Length of hospitalization in days required after thyroidectomy

  • Change in thyroglobulinemia (ng/l) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline

  • Change in calcemia (mg/l) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Calcemia on Day 1 - Calcemia at inclusion

  • Change in calcemia (mg/l) [ Time Frame: Day 7 to 15 ] [ Designated as safety issue: No ]
    Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion

  • Change in calcemia (mg/l) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calcemia at 12 months - Calcemia at inclusion

  • Change in phosphoremia (mg/l) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Phosphoremia at 1 day postop - Phosphoremia at inclusion

  • Change in phosphoremia (mg/l) [ Time Frame: Days 7 to 15 ] [ Designated as safety issue: No ]
    Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion

  • Change in phosphoremia (mg/l) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Phosphoremia at 12 months - Phosphoremia at inclusion

  • Change in parathormonemia (ng/l) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Parathormonemia on Day 1 post-op - parathormonemia at inclusion

  • Change in parathormonemia (ng/l) [ Time Frame: Days 7 to 15 ] [ Designated as safety issue: No ]
    Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion

  • Change in parathormonemia (ng/l) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Parathormonemia at 12 months - parathormonemia at inclusion

  • Visual Analog Pain Score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Visual Analog Scale for pain (0.0 to 10.0)

  • Visual Analog Pain Score [ Time Frame: Days 7 to 15 ] [ Designated as safety issue: No ]
    Visual Analog Scale for pain (0.0 to 10.0)

  • Visual Analog Pain Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Visual Analog Scale for pain (0.0 to 10.0)

  • Direct medical costs (€) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Indirect medical costs (€) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot arm
Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.
 Procedure: Robot-assisted thyroidectomy
Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
Active Comparator: Open surgery
Patients in this arm will have a thyroidectomy using an open surgical technique.
 Procedure: Open thyroidectomy
Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320813

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Benjamin Lallemant, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01320813     History of Changes
Other Study ID Numbers: PHRC-I/2010/BL-01, 2011-A00049-32
Study First Received: March 22, 2011
Last Updated: March 23, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
da vinci robot
Thyroidectomy

Additional relevant MeSH terms:
Goiter
Graves Disease
Thyroid Nodule
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Exophthalmos
Orbital Diseases
Eye Diseases
 Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013