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TerminatedNCT02961322LIRAUpdated May 6, 2023

Medico-economic Study of the Lobo-isthmectomy Assisted Robot

An interventional study of lobo-isthmectomy assisted robot in Lobo-isthmectomy, sponsored by University Hospital, Montpellier. Terminated. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Why this study was terminated
not enough inclusions
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Lobo-isthmectomy
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    lobo isthmectomy

    Other: lobo-isthmectomy assisted robot

Interventions

  • Otherlobo-isthmectomy assisted robot
06

What researchers measure

Primary outcomes

  1. direct medical cost

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02961322
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Nov 10, 2016
Start date
Nov 30, 2016
Primary completion
Nov 10, 2019
Completion
Nov 10, 2019
Last update
May 6, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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