AzTrials
AzTrials

Thyroid NoduleNCT01320813

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

A study testing Robot-assisted thyroidectomy and Open thyroidectomy in people with Thyroid Nodule and Goiter, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Thyroid Nodule, Goiter, Thyroiditis
What is being tested?
Robot-assisted thyroidectomy and Open thyroidectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteFrance
Study dates
Sep 2011to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, Gard, 30029

Other trials in France

About this study

Official title: 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.

Being tested
Robot-assisted thyroidectomy, Open thyroidectomy
Keywords
da vinci robot, Thyroidectomy
Medical subject headings
Thyroid Nodule, Goiter, Thyroiditis, Graves Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted thyroidectomyProcedure or surgery

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

  • Open thyroidectomyProcedure or surgery

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

Study groups in NCT01320813
Study groupRoleWhat they receive
Robot armExperimentalPatients in this arm will have a thyroidectomy performed using a robot-assisted endoscopic technique.
Receives: Procedure: Robot-assisted thyroidectomy
Open surgeryActive comparatorPatients in this arm will have a thyroidectomy using an open surgical technique.
Receives: Procedure: Open thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (21)

  1. Incision size (mm)

    Length of incision in the open group, and sum of incision lengths in the robot group.

    Measured: 12 months

  2. Patient satisfaction score

    Patient satisfaction as regards the incision scar measured using a visual analog scale from 0.0 to 10.0.

    Measured: 12 months

  3. Presence/absence of conversion to open technique

    For patients in the robot arm: presence/absence of conversion to open technique.

    Measured: 1 day

  4. Operating room prep time (min)

    Time in minutes necessary to prep the operating room

    Measured: 1 day

  5. Presence/absence of per-operative complications

    Presence/absence of per-operative complications

    Measured: 1 day

  6. Hospital stay (d)

    Length of hospitalization in days required after thyroidectomy

    Measured: 7 to 15 days post-op

  7. Change in thyroglobulinemia (ng/l)

    Thyroglobulinemia at 12 months - Thryoglobulinemia as baseline

    Measured: 12 months

  8. Change in calcemia (mg/l)

    Calcemia on Day 1 - Calcemia at inclusion

    Measured: Day 1

  9. Change in calcemia (mg/l)

    Calcemia at the control visit (days 7 to 15) - Calcemia at inclusion

    Measured: Day 7 to 15

  10. Change in calcemia (mg/l)

    Calcemia at 12 months - Calcemia at inclusion

    Measured: 12 months

  11. Change in phosphoremia (mg/l)

    Phosphoremia at 1 day postop - Phosphoremia at inclusion

    Measured: Day 1

  12. Change in phosphoremia (mg/l)

    Phosphoremia at control visit (days 7 to 15) - Phosphoremia at inclusion

    Measured: Days 7 to 15

  13. Change in phosphoremia (mg/l)

    Phosphoremia at 12 months - Phosphoremia at inclusion

    Measured: 12 months

  14. Change in parathormonemia (ng/l)

    Parathormonemia on Day 1 post-op - parathormonemia at inclusion

    Measured: Day 1

  15. Change in parathormonemia (ng/l)

    Parathormonemia at control visit (days 7 to 15) - parathormonemia at inclusion

    Measured: Days 7 to 15

  16. Change in parathormonemia (ng/l)

    Parathormonemia at 12 months - parathormonemia at inclusion

    Measured: 12 months

  17. Visual Analog Pain Score

    Visual Analog Scale for pain (0.0 to 10.0)

    Measured: Day 1

  18. Visual Analog Pain Score

    Visual Analog Scale for pain (0.0 to 10.0)

    Measured: Days 7 to 15

  19. Visual Analog Pain Score

    Visual Analog Scale for pain (0.0 to 10.0)

    Measured: 12 months

  20. Direct medical costs (€)

    Measured: 12 months

  21. Indirect medical costs (€)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Why it stopped: Unable to find enough patients who accept randomization of surgical procedures.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01320813
Sponsor's protocol ID
PHRC-I/2010/BL-01
Other IDs
2011-A00049-32
Status last verified
Mar 2015
First submitted
22 Mar 2011
Last updated
25 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted thyroidectomy and Open thyroidectomy in people with Thyroid Nodule and Goiter, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unable to find enough patients who accept randomization of surgical procedures.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence/absence of complications (composite score) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01320813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in