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

Not Applicable

Terminated

• Conditions: Graves Disease; Thyroiditis; Thyroid Nodule; Goiter
• Interventions: Procedure: Robot-assisted thyroidectomy; Procedure: Open thyroidectomy

• Registration Number: NCT01320813
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot arm	Robot-assisted thyroidectomy	Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.
Open surgery	Open thyroidectomy	Patients in this arm will have a thyroidectomy using an open surgical technique.

Primary Outcome Measures

Name	Time	Method
Presence/absence of complications (composite score)	12 months	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

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

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France