Actively Recruiting
A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy
Led by Clinique Bizet · Updated on 2026-01-06
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for thyroid removal: the standard open thyroidectomy and the robotic thyroidectomy performed via an axillary approach. The study focuses on evaluating postoperative pain management, scar appearance, quality of life, and the occurrence of complications such as low calcium levels, neck hematoma, and nerve stimulation. This is a prospective, comparative study conducted at a single center. Participants will undergo either the robotic thyroidectomy through the armpit area or the standard conventional thyroidectomy. The study is not randomized but uses a double-blind setup to compare the two groups. The main period of interest is the 30 days after surgery, with additional assessments at day 7 and at 3 months for some outcomes. During their participation, patients will be asked to complete quality of life questionnaires and have their scar quality and vocal cord function evaluated. Researchers will measure the primary outcome of post-operative quality of life at 30 days. Secondary outcomes include swallowing difficulty scores at multiple time points and scar quality assessments. Participants will be closely monitored for any complications or issues during recovery.
CONDITIONS
Brief Title
Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject aged over 20 years
- Referred for a thyroidectomy (total or partial)
- Not participating in another clinical study
- Affiliated to or beneficiary of a social security scheme
- Agrees to complete the study questionnaires
You will not qualify if you...
- Patient under 20 years of age
- Patients who had combined radical cervical lymph node dissection
- Patient with a postoperative wound problem
- Patient with systemic disease affecting wound healing
- Unable to undergo medical follow-up for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until discharge after surgery
Participants undergo thyroidectomy by either robotic surgery via axillary approach or standard conventional surgery, followed by immediate post-operative care.
1 surgery visit and immediate post-operative care
Duration - 3 months
Participants are followed up to assess recovery including quality of life, dysphagia, scar quality, and vocal cord function.
Visits at Day 7, Day 30, and 3 months post-surgery
Trial Site Locations
Total: 1 location
1
clinique Bizet
Paris, France, 75116
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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