Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07055191

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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