Lobo-isthmectomyLIRANCT02961322
Medico-economic Study of the Lobo-isthmectomy Assisted Robot
A study testing lobo-isthmectomy assisted robot in people with Lobo-isthmectomy, run by University Hospital, Montpellier.
Trial summary
This is a study of health economics longitudinal cohort on the evaluation of direct medical cost of a surgical technique based on the use of an innovative device (the da Vinci® surgical robot Si) and its comprehensive care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lobo-isthmectomy
- What is being tested?
- lobo-isthmectomy assisted robot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2016to 10 Nov 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient candidate for thyroid lobectomy or lobo-isthmectomy for benign nodular disease
- normal laryngeal mobility (clinical evaluation by an ENT (Ear-Nose-Throat) Doctor)
- breast cancer absence being supported
- No suspected thyroid cancer
- Nodules size <6cm
- Confirm Benin character nodules by fine needle biopsy made within 6 months prior to patient inclusion
- Patient available for post-operative follow-up of 12 months
Who cannot join
- Patient participating or having participated in another interventional study in the previous 3 months or exclusion period determined by a previous study
- Patient under guardianship or trusteeship or under judicial protection
- Inability to give informed patient information
- Pregnant women, breastfeeding or parturient
- Contraindications (or incompatible combination therapy) for a necessary treatment in this study
- contraindication to general anesthesia
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- Emergencies
- Breast Cancer being supported
- treatment or surgical sentinel node of the planned breast cancer
- thyroid nodule ranked in the ultrasound TIRADS 5 (Thyroid image reporting and data system)
- Fine needle aspiration biopsy with BETHESDA score result 5 and 6
- Plunging Nodule
About this study
This is a study of health economics longitudinal cohort on the evaluation of direct medical cost of a surgical technique based on the use of an innovative device (the da Vinci® surgical robot Si) and its comprehensive care.
Read the detailed description
Over 50,000 thyroidectomies are performed each year in France. The externally surgery produces satisfactory results, but it nevertheless remains a risk of complications in the order of 10 to 20%. Moreover, the patients operated by traditional externally have a basi-cervical visible scar which is a major concern for many of them. The team of Montpellier University Hospital is a pioneer in the use of the technique of endoscopic thyroidectomy under robotic assistance that saves totally cervical scarring for patients, but also decrease the rate of complications. This technique based on the use of the da Vinci robotic system if justified, depending on the manufacturer and the scientific literature, with its minimally invasive character, an amplitude of greater movement than the hand of man, and movements called intuitive that reduce tremors instruments during the operation (Patel 2008). In France and in Europe, there is a growing demand from patients and surgeons to access the surgical technique. An assessment of the real and specific cost of this technique and its overall management is essential in order to assess the financial impact of the introduction of this surgery for our hospitals, or no data is available on this in Literature.
The main objective of this study is to describe the direct medical cost of the treatment of thyroid Lobo-Isthmectomy Robot-Assisted (LIRA) with a follow-up 12 months. The secondary objectives of this research are to determine the rate of laryngeal paralysis, the rate of complications specific to access axillary robot, the size of the incision made for surgery, the number of channel conversion transaxillary assisted robot traditional externally, to assess the satisfaction of each patient over his scar, pain over time, the evolution of potential disorders sensitivity of anterior chest wall, the vocal functional suites and quality of life self-administered questionnaire (Voice handicap Index VHI 10 and Short Forme SF-36), and finally to compare the cost of care by the robot with the average cost of a conventional surgery.
- Conditions
- Lobo-isthmectomy
- Being tested
- lobo-isthmectomy assisted robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lobo-isthmectomy assisted robotOther
| Study group | Role | What they receive |
|---|---|---|
| lobo isthmectomy | Experimental | Not described Receives: Other: lobo-isthmectomy assisted robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
direct medical cost
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start30 Nov 2016
- Primary completion10 Nov 2019
- Study completion10 Nov 2019
Why it stopped: not enough inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobo-isthmectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961322
- Sponsor's protocol ID
- 9657
- Acronym
- LIRA
- Status last verified
- May 2023
- First submitted
- 8 Nov 2016
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Study of the Lobo-isthmectomy Assisted Robot
- ClinicalTrials.gov ID
- NCT02961322
- Acronym / sponsor ID
- LIRA / 9657
- Conditions
- Lobo-isthmectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough inclusions
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of health economics longitudinal cohort on the evaluation of direct medical cost of a surgical technique based on the use of an innovative device (the da Vinci® surgical robot Si) and its comprehensive care.
Detailed description
Over 50,000 thyroidectomies are performed each year in France. The externally surgery produces satisfactory results, but it nevertheless remains a risk of complications in the order of 10 to 20%. Moreover, the patients operated by traditional externally have a basi-cervical visible scar which is a major concern for many of them. The team of Montpellier University Hospital is a pioneer in the use of the technique of endoscopic thyroidectomy under robotic assistance that saves totally cervical scarring for patients, but also decrease the rate of complications. This technique based on the use of the da Vinci robotic system if justified, depending on the manufacturer and the scientific literature, with its minimally invasive character, an amplitude of greater movement than the hand of man, and movements called intuitive that reduce tremors instruments during the operation (Patel 2008). In France and in Europe, there is a growing demand from patients and surgeons to access the surgical technique. An assessment of the real and specific cost of this technique and its overall management is essential in order to assess the financial impact of the introduction of this surgery for our hospitals, or no data is available on this in Literature.
The main objective of this study is to describe the direct medical cost of the treatment of thyroid Lobo-Isthmectomy Robot-Assisted (LIRA) with a follow-up 12 months. The secondary objectives of this research are to determine the rate of laryngeal paralysis, the rate of complications specific to access axillary robot, the size of the incision made for surgery, the number of channel conversion transaxillary assisted robot traditional externally, to assess the satisfaction of each patient over his scar, pain over time, the evolution of potential disorders sensitivity of anterior chest wall, the vocal functional suites and quality of life self-administered questionnaire (Voice handicap Index VHI 10 and Short Forme SF-36), and finally to compare the cost of care by the robot with the average cost of a conventional surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lobo isthmectomy | Experimental | Other: lobo-isthmectomy assisted robot |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient candidate for thyroid lobectomy or lobo-isthmectomy for benign nodular disease
- normal laryngeal mobility (clinical evaluation by an ENT (Ear-Nose-Throat) Doctor)
- breast cancer absence being supported
- No suspected thyroid cancer
- Nodules size <6cm
Key exclusion criteria (12 listed)
- Patient participating or having participated in another interventional study in the previous 3 months or exclusion period determined by a previous study
- Patient under guardianship or trusteeship or under judicial protection
- Inability to give informed patient information
- Pregnant women, breastfeeding or parturient
- Contraindications (or incompatible combination therapy) for a necessary treatment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lobo-isthmectomy assisted robot | Other | lobo isthmectomy |
Primary outcome
direct medical cost
Time frame: 12 months
Results and safety
The study was stopped early (reason given: not enough inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing lobo-isthmectomy assisted robot in people with Lobo-isthmectomy, run by University Hospital, Montpellier.
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 7 inclusion and 12 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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: not enough inclusions). 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?
direct medical cost (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.