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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01320813
• Other study ID #: PHRC-I/2010/BL-01
• Secondary ID: 2011-A00049-32
• Status: Terminated
• Phase: N/A
• First received: March 22, 2011
• Last updated: March 24, 2015
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Goiter
• Graves Disease
• Thyroid Nodule
• Thyroiditis

Intervention

Procedure:
• Robot-assisted thyroidectomy
Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
• Open thyroidectomy
Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incision size (mm)	Length of incision in the open group, and sum of incision lengths in the robot group.	12 months	No
Secondary	Patient satisfaction score	Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.	12 months	No
Secondary	Presence/absence of conversion to open technique	For patients in the robot arm: presence/absence of conversion to open technique.	1 day	Yes
Secondary	Operating room prep time (min)	Time in minutes necessary to prep the operating room	1 day	No
Secondary	Presence/absence of per-operative complications	Presence/absence of per-operative complications	1 day	Yes
Secondary	Hospital stay (d)	Length of hospitalization in days required after thyroidectomy	7 to 15 days post-op	No
Secondary	Change in thyroglobulinemia (ng/l)	Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline	12 months	No
Secondary	Change in calcemia (mg/l)	Calcemia on Day 1 - Calcemia at inclusion	Day 1	No
Secondary	Change in calcemia (mg/l)	Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion	Day 7 to 15	No
Secondary	Change in calcemia (mg/l)	Calcemia at 12 months - Calcemia at inclusion	12 months	No
Secondary	Change in phosphoremia (mg/l)	Phosphoremia at 1 day postop - Phosphoremia at inclusion	Day 1	No
Secondary	Change in phosphoremia (mg/l)	Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion	Days 7 to 15	No
Secondary	Change in phosphoremia (mg/l)	Phosphoremia at 12 months - Phosphoremia at inclusion	12 months	No
Secondary	Change in parathormonemia (ng/l)	Parathormonemia on Day 1 post-op - parathormonemia at inclusion	Day 1	No
Secondary	Change in parathormonemia (ng/l)	Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion	Days 7 to 15	No
Secondary	Change in parathormonemia (ng/l)	Parathormonemia at 12 months - parathormonemia at inclusion	12 months	No
Secondary	Visual Analog Pain Score	Visual Analog Scale for pain (0.0 to 10.0)	Day 1	No
Secondary	Visual Analog Pain Score	Visual Analog Scale for pain (0.0 to 10.0)	Days 7 to 15	No
Secondary	Visual Analog Pain Score	Visual Analog Scale for pain (0.0 to 10.0)	12 months	No
Secondary	Direct medical costs (€)		12 months	No
Secondary	Indirect medical costs (€)		12 months	No