NCT01320813

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

March 22, 2011

Last Update Submit

March 24, 2015

Conditions

Thyroid NoduleGoiterThyroiditisGraves Disease

Keywords

da vinci robotThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (21)

  • Incision size (mm)

    12 months

  • Patient satisfaction score

    12 months

  • Presence/absence of conversion to open technique

    1 day

  • Operating room prep time (min)

    1 day

  • Presence/absence of per-operative complications

    1 day

  • +16 more secondary outcomes

Study Arms (2)

Robot arm

EXPERIMENTAL

Patients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.

Procedure: Robot-assisted thyroidectomy

Open surgery

ACTIVE COMPARATOR

Patients in this arm will have a thyroidectomy using an open surgical technique.

Procedure: Open thyroidectomy

Interventions

Robot-assisted thyroidectomyPROCEDURE

Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.

Robot arm
Open thyroidectomyPROCEDURE

Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique

Open surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Thyroid NoduleGoiterThyroiditisGraves Disease

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesExophthalmosOrbital DiseasesEye DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Officials

  • Benjamin Lallemant, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

FR(1)