TOETVA Technique Compared With Anterior Cervical Thyroidectomy (AC) in Terms of Efficacy and Safety

NCT07055191 | Recruiting DMC

• 3 other identifiers: 2022_0509PHRC-21-03402022-A02301-42
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 10

Brief Summary

Nearly 50,000 thyroidectomies are performed in France each year for benign and malignant pathologies. Each one affects the life of the patient and represents, for some, suffering, symbolized by the stigma of the operation. The consequences of these scars vary according to the patient, their experience and their culture. For example, cervicotomies are particularly badly accepted in Asia since they are supposed to interrupt the fertility meridian. In France, increasing attention is being paid to the global management of a person with some disease. As a disease state may be transitory, the medical team must consider the situation "after the illness" and plan a return to normality. In particular, alternative approaches to cervicotomy have been developed, in which the scar is in a less visible location, at the cost of a more extensive dissection. These techniques include the transaxillary approach, the bi-areolar biaxillary approach and the retroauricular approach. Such procedures, initially developed as an endoscopic approach, have become progressively robotically assisted, to help with the ergonomics of the procedure. Even though robotic assistance initially helped to spread use of these techniques, it has, over time, limited them, first because of higher cost, and second because of the high learning curve (50 to 75 cases). Finally, the transaxillary approach, which is the most commonly performed, has an inherent problem due to the decreased visibility of the noble structures on the contralateral side, leading to frequent subtotal resection. Since 2014, the Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) has been developed as an alternative to these robot-assisted procedures. Because this technique offers the surgeon similar access to the anatomical structures on both sides of the trachea and makes it possible to identify the noble structures to be preserved, TOETVA is currently undergoing a more widespread use in France and worldwide and more candidates for are being offered the procedure. TOETVA reduces the need for dissection to reach the thyroid gland. Moreover, this procedure does not require any special equipment, even if robotic assistance has been used in transoral thyroidectomy. Just like the electric light was not developed from the continuous improvement of candles, entirely new approaches are sometimes necessary in surgery. The Scientific Committee of the French Association of Endocrine Surgery is convinced that TOETVA, will become more widely used in France, even if this technique is a major departure from the standard approach. However, it is technically more demanding and must, therefore, be evaluated and supervised. This will require a safety study and a comparison with the current reference procedure, the anterior cervical thyroidectomy (AC). The investigators assume, based on our initial experience, that the use of endoscopic equipment and its magnification will allow good visualization of the noble elements (recurrent nerve and parathyroid glands) and that the complication rate of TOETVA will not be higher than that of the reference approach. The investigators propose to evaluate, through a prospective randomized study, an innovative endocrine surgical technique that has started to be used worldwide. Although this study is in line with the objectives of an evaluation of the pertinence of care by the health authorities, it would be the first assessment of this innovative surgical technique in thyroid surgery. To our knowledge, after an extensive bibliographic search, no prospective multicenter randomized trial comparing TOETVA to AC has yet been performed, even if many cohorts of patients have been reported to have benefited from this approach6. In this trial, any change to the quality of life will be extensively evaluated. The use of validated scores to quantify pain and quality of life will provide objective information and make it possible to determine the impact of the presence or absence of a scar.

Conditions

Lobectomy; Thyroidectomy

Keywords

Endocrinology; thyroidectomy; mini-invasive; TransOral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA); Anterior Cervical thyroidectomy (AC)

Outcome Measures

Primary Outcomes (1)

• To demonstrate the non-inferiority of TOETVA compared to AC in terms of early postoperative complications (during the first 24 hours) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure.

  The rate of patients with early postoperative complications defined by the occurrence of at least one of the following events within the first 24 hours: * Recurrent paralysis, defined by abnormal vocal cord mobility; * Hypoparathyroidism: defined by calcium level\<80 mg/L and/or parathyroid hormone level\<15 pg/mL; * Hematoma: defined by the need for additional surgery to drain the hematoma

  during the first 24 hours

Secondary Outcomes (5)

• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the rate of mid-term postoperative complications

  within 30 days of surgery

• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the quality of life at 1 month after surgery

  at 1 month after surgery

• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the quality of life at 6 months after surgery

  at 6 months after surgery

• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the evolution of pain at 1 month after surgery

  at 1 month after surgery

• To compare, between the two surgical approaches (TOETVA vs. AC) in patients with a surgical indication for lobectomy or total thyroidectomy without associated lymph node procedure, the evolution of pain at 6 months after surgery

  at 6 months after surgery

Study Arms (2)

Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

EXPERIMENTAL

Procedure: Transoral Endoscopic Thyroidectomy by Vestibular Approach

Anterior Cervical thyroidectomy (AC)

ACTIVE COMPARATOR

Procedure: Anterior Cervical thyroidectomy

Interventions

Transoral Endoscopic Thyroidectomy by Vestibular Approach PROCEDURE

Transoral Endoscopic Thyroidectomy by Vestibular Approach

Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

Anterior Cervical thyroidectomy PROCEDURE

Anterior Cervical thyroidectomy

Anterior Cervical thyroidectomy (AC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (10)

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

Central Study Contacts

Robert Caiazzo, Prof.

CONTACT

+33 (0)3 20 44 55 15; robert.caiazzo@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: July 8, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

FR (10)