Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Bizet

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • thyroidectomy by robotic surgery via axillary approach

    Procedure/Surgery

    thyroidectomy

  • thyroidectomy by standard conventional surgery

    Procedure/Surgery

    thyroidectomy by standard conventional surgery

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the post-operative quality of life at D30 between the two groups

thyca-Qol

Time frame
day 30

Secondary outcomes

1

Total dysphagia score between the two groups

EAT-10 scale

Time frame
Day7, Day30 and 3 months
2

Quality of the scar between the two groups

Vancouver scale

Time frame
day 30
3

Assess the functional recovery of the vocal cords

fibroscopy

Time frame
day 7 and day 30

Other outcomes

Sponsors and contacts

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