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

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

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.

Study Overview

• Status: Terminated
• Conditions: Graves Disease; Goiter; Thyroid Nodule; Thyroiditis
• Intervention / Treatment: Procedure: Robot-assisted thyroidectomy; Procedure: Open thyroidectomy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incision size (mm)	Length of incision in the open group, and sum of incision lengths in the robot group.	12 months
Patient satisfaction score	Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.	12 months
Presence/absence of conversion to open technique	For patients in the robot arm: presence/absence of conversion to open technique.	1 day
Operating room prep time (min)	Time in minutes necessary to prep the operating room	1 day
Presence/absence of per-operative complications	Presence/absence of per-operative complications	1 day
Hospital stay (d)	Length of hospitalization in days required after thyroidectomy	7 to 15 days post-op
Change in thyroglobulinemia (ng/l)	Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline	12 months
Change in calcemia (mg/l)	Calcemia on Day 1 - Calcemia at inclusion	Day 1
Change in calcemia (mg/l)	Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion	Day 7 to 15
Change in calcemia (mg/l)	Calcemia at 12 months - Calcemia at inclusion	12 months
Change in phosphoremia (mg/l)	Phosphoremia at 1 day postop - Phosphoremia at inclusion	Day 1
Change in phosphoremia (mg/l)	Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion	Days 7 to 15
Change in phosphoremia (mg/l)	Phosphoremia at 12 months - Phosphoremia at inclusion	12 months
Change in parathormonemia (ng/l)	Parathormonemia on Day 1 post-op - parathormonemia at inclusion	Day 1
Change in parathormonemia (ng/l)	Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion	Days 7 to 15
Change in parathormonemia (ng/l)	Parathormonemia at 12 months - parathormonemia at inclusion	12 months
Visual Analog Pain Score	Visual Analog Scale for pain (0.0 to 10.0)	Day 1
Visual Analog Pain Score	Visual Analog Scale for pain (0.0 to 10.0)	Days 7 to 15
Visual Analog Pain Score	Visual Analog Scale for pain (0.0 to 10.0)	12 months
Direct medical costs (€)		12 months
Indirect medical costs (€)		12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Thyroidectomy; da vinci robot
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Autoimmune Diseases; Neoplasms by Site; Eye Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Neoplasms; Thyroid Nodule; Graves Disease; Thyroiditis
• Other Study ID Numbers: PHRC-I/2010/BL-01; 2011-A00049-32 (Other Identifier: RCB number)