Actively Recruiting
Prospective Randomized Multicenter Trial Comparing the Safety and Efficacy of Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Versus Anterior Cervical Thyroidectomy (AC)
Led by University Hospital, Lille · Updated on 2026-01-16
616
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) compared to the traditional Anterior Cervical thyroidectomy (AC) in patients needing lobectomy or total thyroidectomy without lymph node procedures. This study aims to assess whether TOETVA, a newer surgical technique avoiding neck scars, is as safe and effective as the standard AC method. The trial focuses on early and mid-term postoperative complications, quality of life, and pain levels after surgery. The study involves two groups: one receiving the TOETVA procedure and the other undergoing the AC surgery. TOETVA uses an endoscopic approach through the mouth to access the thyroid gland, potentially reducing visible scarring and tissue dissection. The AC procedure is the conventional open surgery with a neck incision. The trial will compare outcomes such as complication rates and patient recovery between these two surgical methods. Participants will be monitored for complications during the first 24 hours and up to 30 days after surgery. Quality of life and pain will be assessed at one month and six months post-operation using validated measures. The study includes follow-up visits to evaluate healing and patient well-being. Participation lasts through the surgical treatment and follow-up assessments, ensuring thorough evaluation of both surgical techniques.
CONDITIONS
Brief Title
TOETVA Technique Compared With Anterior Cervical Thyroidectomy (AC) in Terms of Efficacy and Safety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a surgical indication for lobectomy or thyroidectomy
- Thyroid volume less than 60 mL measured by ultrasonography
- Nodules suspected to be malignant measuring less than 4 cm
- Age between 18 and 65 years old
- Endocrinological evaluation with favorable opinion for TOETVA or AC
- Patient understands and agrees to follow-up
- Patient agrees to participate and signs informed consent
- Patient is affiliated with a healthcare insurance plan
You will not qualify if you...
- Patients refusing AC or any alternative to AC
- History of cervical surgery
- Associated parathyroid surgery
- Malignant lymph nodes identified
- Severe, progressive life-threatening illness
- Unstable psychiatric disorder, under supervision or guardianship
- Patients unable to understand French or give consent
- Not affiliated with French or European healthcare insurance
- Previously included in conflicting clinical trials
- Pregnant or breastfeeding patients
- Patients who are incarcerated
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours
Participants undergo either Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) or Anterior Cervical Thyroidectomy (AC), followed by immediate post-operative care.
1 surgical visit and immediate post-operative monitoring
Duration - 6 months
Participants are monitored for mid-term postoperative complications and recovery, including quality of life and pain assessments at 1 and 6 months after surgery.
Visits at 1 month and 6 months after surgery
Trial Site Locations
Total: 10 locations
1
AP-HP - Hôpital Avicennes
Bobigny, France
Not Yet Recruiting
2
Hôpital Franco-Britannique
Levallois-Perret, France
Not Yet Recruiting
3
CHU de Lille, Hôpital Huriez
Lille, France
Actively Recruiting
4
CHU Dupuytren
Limoges, France
Not Yet Recruiting
5
CHU de Nantes - Hôtel Dieu
Nantes, France
Not Yet Recruiting
6
AP-HP - Hôpital Cochin
Paris, France
Not Yet Recruiting
7
Hôpital Lyon Sud
Pierre-Bénite, France
Not Yet Recruiting
8
CHU de Poitiers
Poitiers, France
Not Yet Recruiting
9
Polyclinique de la Côte Basque Sud
Saint-Jean-de-Luz, France
Not Yet Recruiting
10
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
Research Team
R
Robert Caiazzo, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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