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

University Hospital, Lille

Status

Enrolling

Conditions

Thyroidectomy

Lobectomy

Treatments

Procedure: Anterior Cervical thyroidectomy

Procedure: Transoral Endoscopic Thyroidectomy by Vestibular Approach

Study type

Interventional

Funder types

Other

Identifiers

NCT07055191

2022_0509

PHRC-21-0340 (Other Grant/Funding Number)

2022-A02301-42 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

616 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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