Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: thyroidectomy by robotic surgery via axillary approach, thyroidectomy by standard conventional surgery.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy
Overview
The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)
Interventions
- Procedure thyroidectomy by robotic surgery via axillary approach
thyroidectomy - Procedure thyroidectomy by standard conventional surgery
thyroidectomy by standard conventional surgery
Primary outcome measures
- Evaluate the post-operative quality of life at D30 between the two groups [Time frame: day 30]
Secondary outcome measures (3)
- Total dysphagia score between the two groups [Time frame: Day7, Day30 and 3 months]
- Quality of the scar between the two groups [Time frame: day 30]
- Assess the functional recovery of the vocal cords [Time frame: day 7 and day 30]
Eligibility criteria
Inclusion criteria
- Subject aged over 20 years
- Referred for a thyroidectomy (total or partial)
- Absence of participation in another clinical study
- Subject affiliated to a social security scheme or beneficiary of such a scheme
- Accepts the completion of the various study questionnaires
Exclusion criteria
- Patient under 20 years of age.
- Patients who have undergone combined radical cervical lymph node dissection
- Patient with a postoperative wound problem
- Patient with an underlying systemic disease that may influence the wound healing process
- Unable to undergo medical follow-up for the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- clinique Bizet — Paris
Identifiers
NCT: NCT06693258 · 2024-A01697-40