Transoral (TOETVA) versus standard front‑neck (anterior cervical) thyroid surgery for lobectomy or thyroidectomy
Prospective Randomized Multicenter Trial Comparing the Efficacy and Safety of the Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Versus Anterior Cervical Thyroidectomy (AC)
NA · University Hospital, Lille · NCT07055191
This trial will test whether the transoral (TOETVA) scar‑hiding approach works as well and is as safe as the standard front‑neck (anterior cervical) operation for adults needing lobectomy or thyroidectomy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 616 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 10 sites (Bobigny and 9 other locations) |
| Trial ID | NCT07055191 on ClinicalTrials.gov |
What this trial studies
This interventional comparison enrolls adults 18–65 who need a lobectomy or thyroidectomy and have a thyroid volume under 60 mL and nodules under 4 cm. Participants receive either transoral endoscopic thyroidectomy by vestibular approach (TOETVA) or conventional anterior cervical (AC) thyroidectomy, with perioperative care and planned follow‑up. Outcomes include surgical efficacy, complication rates, cosmetic results, and recovery metrics such as pain and return to normal activities. The protocol excludes patients with prior cervical surgery, identified malignant lymph nodes, associated parathyroid procedures, or unstable severe illness, and is run at several French university and regional hospitals.
Who should consider this trial
Good fit: Adults aged 18–65 who need a lobectomy or thyroidectomy, have thyroid volume <60 mL and nodules <4 cm, have not had prior neck surgery, and can give informed consent and attend follow‑up are ideal candidates.
Not a fit: Patients with prior cervical surgery, identified malignant lymph nodes, required parathyroid procedures, severe life‑threatening comorbidities, or inability to consent (including non‑French speakers) are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the transoral approach could reduce visible neck scarring and improve cosmetic satisfaction while keeping safety and surgical results comparable.
How similar studies have performed: Existing case series and observational reports of TOETVA show comparable complication rates and improved cosmetic outcomes versus open neck surgery, but randomized direct comparisons are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a surgical indication for lobectomy or thyroidectomy * Estimated thyroid volume measured by ultrasonography of less than 60 mL * Nodules suspected to be malignant measuring less than 4 cm * Patient aged between 18 and 65 years old * Patient who has benefited from an endocrinological evaluation, with a favorable opinion for TOETVA or AC Patient who understands and accepts the need for follow-up * Patient who agrees to be included in the study and who signs the informed consent form * Patient affiliated to a healthcare insurance plan Exclusion Criteria: * Patients refusing an alternative to AC or refusing AC * History of cervical surgery * Associated parathyroid surgery * Identification of malignant lymph nodes * Presence of a severe and evolutive life threatening pathology * Patients with unstable psychiatric disorder, under supervision or guardianship * Patient who does not understand French/ is unable to give consent * Patient not affiliated to a French or European healthcare insurance * Patient who has already been included in a trial which has a conflict of interests with the present study * Pregnant or breast-feeding patient * Patient incarcerated
Where this trial is running
Bobigny and 9 other locations
- AP-HP - Hôpital Avicennes — Bobigny, France (NOT_YET_RECRUITING)
- Hôpital Franco-Britannique — Levallois-Perret, France (NOT_YET_RECRUITING)
- CHU de Lille, Hôpital Huriez — Lille, France (RECRUITING)
- CHU Dupuytren — Limoges, France (NOT_YET_RECRUITING)
- CHU de Nantes - Hôtel Dieu — Nantes, France (NOT_YET_RECRUITING)
- AP-HP - Hôpital Cochin — Paris, France (NOT_YET_RECRUITING)
- Hôpital Lyon Sud — Pierre-Bénite, France (NOT_YET_RECRUITING)
- CHU de Poitiers — Poitiers, France (NOT_YET_RECRUITING)
- Polyclinique de la Côte Basque Sud — Saint-Jean-de-Luz, France (NOT_YET_RECRUITING)
- CHRU de Nancy Brabois — Vandœuvre-lès-Nancy, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Robert Caiazzo, Prof.
- Email: robert.caiazzo@chu-lille.fr
- Phone: +33 (0)3 20 44 55 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lobectomy, Thyroidectomy, Endocrinology, thyroidectomy, mini-invasive, TransOral Endoscopic Thyroidectomy by Vestibular Approach, Anterior Cervical thyroidectomy