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Clinical Trial NCT07055191 (THYRORAL) for Lobectomy, Thyroidectomy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University Hospital, LilleTOETVA Technique Compared With Anterior Cervical Thyroidectomy (AC) in Terms of Efficacy and Safety (THYRORAL) 616 Randomized
Clinical Trial NCT07055191 (THYRORAL) is an interventional study for Lobectomy, Thyroidectomy that is recruiting. It started on 7 November 2025 with plans to enroll 616 participants. Led by University Hospital, Lille, it is expected to complete by 1 November 2028. The latest data from ClinicalTrials.gov was last updated on 16 January 2026.
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 inte...Show More
Official Title
Prospective Randomized Multicenter Trial Comparing the Efficacy and Safety of the Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) Versus Anterior Cervical Thyroidectomy (AC)
Conditions
LobectomyThyroidectomyOther Study IDs
- THYRORAL
- 2022_0509
- PHRC-21-0340 (Other Grant/Funding Number) (PHRC-N)
- 2022-A02301-42 (Other Identifier) (ID-RCB number, ANSM)
NCT ID Number
Start Date (Actual)
2025-11-07
Last Update Posted
2026-01-16
Completion Date (Estimated)
2028-11
Enrollment (Estimated)
616
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Endocrinology
thyroidectomy
mini-invasive
TransOral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
Anterior Cervical thyroidectomy (AC)
thyroidectomy
mini-invasive
TransOral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
Anterior Cervical thyroidectomy (AC)
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTransoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA) | Transoral Endoscopic Thyroidectomy by Vestibular Approach Transoral Endoscopic Thyroidectomy by Vestibular Approach |
Active ComparatorAnterior Cervical thyroidectomy (AC) | Anterior Cervical thyroidectomy Anterior Cervical thyroidectomy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | The rate of patients with mid-term postoperative complications defined by the occurrence of at least one of the following events within the 30 postoperative days:
* Symptomatic hypocalcemia secondary to hypoparathyroidism: defined by initiation of calcium supplementation;
* Hematoma: defined by the a revision surgery for hematoma;
* Infection: defined by revision surgery for infection or the initiation of an antibiotic therapy, apart from perioperative antibiotic prophylaxis for the TOETVA group. | 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 | Quality of life scores assessed at 1 month using the 36-Item Short Form Survey (SF-36), the Voice handicap index (VHI) and the Swallowing Impairment Score (SIS) questionnaires.
SF36: score from 0 to 100. Higher scores mean a better outcome. VHI: score from 0 to 120. Higher scores mean a worse outcome. SIS: score from 0 to 24. Higher scores mean a worse outcome. | 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 | Quality of life scores assessed at 6 months using the 36-Item Short Form Survey (SF-36), the Voice handicap index (VHI) and the Swallowing Impairment Score (SIS) questionnaires.
SF36: score from 0 to 100. Higher scores mean a better outcome. VHI: score from 0 to 120. Higher scores mean a worse outcome. SIS: score from 0 to 24. Higher scores mean a worse outcome. | 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 | Change in pain at 1 month from baseline (preoperative assessment), assessed using two validated scores: (1) the visual analogue scale (VAS) in five areas (lower lip, chin, jaw, anterior neck, and cervix/back) and during four actions (swallowing, brushing teeth, speaking, and shaving), which is the only one that has been validated for TOETVA and (2) the DN4 (Neuropathic Pain 4 Questions), which is widely used in the literature. | 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 | Change in pain at 6 months from baseline (preoperative assessment), assessed using two validated scores: (1) the visual analogue scale (VAS) in five areas (lower lip, chin, jaw, anterior neck, and cervix/back) and during four actions (swallowing, brushing teeth, speaking, and shaving), which is the only one that has been validated for TOETVA and (2) the DN4 (Neuropathic Pain 4 Questions), which is widely used in the literature. | at 6 months after surgery |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
University Hospital, LilleMinistry of Health, FranceStudy Central Contact
Contact: Robert Caiazzo, Prof., +33 (0)3 20 44 55 15, [email protected]
10 Study Locations in 1 Countries
AP-HP - Hôpital Avicennes, Bobigny, France
Christophe Tresallet, Doc., Contact, +33(0)1 48 02 61 95, [email protected]
Not yet recruiting
Hôpital Franco-Britannique, Levallois-Perret, France
Grégoire Deroide, Doc., Contact, +33(0)1 56 83 08 84, [email protected]
Not yet recruiting
CHU de Lille, Hôpital Huriez, Lille, France
Robert Caiazzo, Prof., Contact, +33(0)320445515, [email protected]
Recruiting
CHU Dupuytren, Limoges, France
Muriel Mathonnet, Prof., Contact, +33(0)5 55 05 62 12, [email protected]
Not yet recruiting
CHU de Nantes - Hôtel Dieu, Nantes, France
Eric Mirallié, Prof., Contact, +33(0)2 40 08 31 66, [email protected]
Not yet recruiting
AP-HP - Hôpital Cochin, Paris, France
Martin Gaillard, Doc., Contact, +33(0)1 58 41 17 58, [email protected]
Not yet recruiting
Hôpital Lyon Sud, Pierre-Bénite, France
Laure Maillard, Doc., Contact, +33(0)4 78 86 23 70, [email protected]
Not yet recruiting
CHU de Poitiers, Poitiers, France
Gianluca Donatini, Doc., Contact, +33(0)5 49 44 43 21, [email protected]
Not yet recruiting
Polyclinique de la Côte Basque Sud, Saint-Jean-de-Luz, France
Isabelle Honigman-Bueno, Doc., Contact, +33(0)5 59 51 63 67, [email protected]
Not yet recruiting
CHRU de Nancy Brabois, Vandœuvre-lès-Nancy, France
Nominé-Criqui Claire, Doc., Contact, +33(0)3 83 15 78 26, [email protected]
Not yet recruiting