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

March 24, 2015 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence/absence of complications (composite score)
Time Frame: 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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incision size (mm)
Time Frame: 12 months
Length of incision in the open group, and sum of incision lengths in the robot group.
12 months
Patient satisfaction score
Time Frame: 12 months
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
Time Frame: 1 day
For patients in the robot arm: presence/absence of conversion to open technique.
1 day
Operating room prep time (min)
Time Frame: 1 day
Time in minutes necessary to prep the operating room
1 day
Presence/absence of per-operative complications
Time Frame: 1 day
Presence/absence of per-operative complications
1 day
Hospital stay (d)
Time Frame: 7 to 15 days post-op
Length of hospitalization in days required after thyroidectomy
7 to 15 days post-op
Change in thyroglobulinemia (ng/l)
Time Frame: 12 months
Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline
12 months
Change in calcemia (mg/l)
Time Frame: Day 1
Calcemia on Day 1 - Calcemia at inclusion
Day 1
Change in calcemia (mg/l)
Time Frame: Day 7 to 15
Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion
Day 7 to 15
Change in calcemia (mg/l)
Time Frame: 12 months
Calcemia at 12 months - Calcemia at inclusion
12 months
Change in phosphoremia (mg/l)
Time Frame: Day 1
Phosphoremia at 1 day postop - Phosphoremia at inclusion
Day 1
Change in phosphoremia (mg/l)
Time Frame: Days 7 to 15
Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion
Days 7 to 15
Change in phosphoremia (mg/l)
Time Frame: 12 months
Phosphoremia at 12 months - Phosphoremia at inclusion
12 months
Change in parathormonemia (ng/l)
Time Frame: Day 1
Parathormonemia on Day 1 post-op - parathormonemia at inclusion
Day 1
Change in parathormonemia (ng/l)
Time Frame: Days 7 to 15
Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion
Days 7 to 15
Change in parathormonemia (ng/l)
Time Frame: 12 months
Parathormonemia at 12 months - parathormonemia at inclusion
12 months
Visual Analog Pain Score
Time Frame: Day 1
Visual Analog Scale for pain (0.0 to 10.0)
Day 1
Visual Analog Pain Score
Time Frame: Days 7 to 15
Visual Analog Scale for pain (0.0 to 10.0)
Days 7 to 15
Visual Analog Pain Score
Time Frame: 12 months
Visual Analog Scale for pain (0.0 to 10.0)
12 months
Direct medical costs (€)
Time Frame: 12 months
12 months
Indirect medical costs (€)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHRC-I/2010/BL-01
  • 2011-A00049-32 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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