Study on Thyroid Surgery with Endoscopic Access Compared to Conventional

Prospective randomized study of efficacy, safety, cosmetic satisfaction and quality of life of patients undergoing endoscopic thyroidectomy via transvestibular access and comparison with conventional access

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-73dhv4f

Enrollment

Registered

2026-02-18

Start date

2025-06-15

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Interventions

This is a prospective, randomized, controlled, open-label, two-arm parallel clinical study. The study will include a total of forty participants, with twenty participants allocated to the Experimental

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants over 18 years of age treated at the Instituto do Câncer Arnaldo Vieira de Carvalho; patients with thyroid nodules classified as Bethesda III, IV, V or VI with a maximum diameter of 2 cm; patients with thyroid volume up to 25 cubic centimeters; participants who are aware of the proposed treatments, agree to undergo the procedure and sign the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: Arm Benign Nodules and Arm Malignant Nodules Participants with thyroid nodules Bethesda III, IV, V and VI who at preoperative evaluation present nodules larger than 2 cm or clinical or radiological evidence of thyroid capsule invasion or lymph node metastasis; participants with thyroid diameter greater than 10 cm; participants with acute hyperthyroidism; participants with vocal cord paralysis at preoperative evaluation; participants without cognitive ability to understand the informed consent form.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of transoral access via a vestibular approach for thyroid and parathyroid surgery through the overall complication rate, length of hospital stay, percentage and intensity of dysphonia, parathyroid hormone (PTH) levels, need for blood transfusion, need for postoperative ICU care, occurrence of complications specific to the transvestibular technique such as skin perforation, air embolism, mental nerve paresis, pneumomediastinum, pneumothorax and pneumoperitoneum, as well as cervical infection, seroma, hematoma, airway injury, vascular injury, need for reoperation, recurrence rate and disease persistence.	—

Measure

Time frame

To evaluate the safety of transoral access via a vestibular approach for thyroid and parathyroid surgery through the overall complication rate, length of hospital stay, percentage and intensity of dysphonia, parathyroid hormone (PTH) levels, need for blood transfusion, need for postoperative ICU care, occurrence of complications specific to the transvestibular technique such as skin perforation, air embolism, mental nerve paresis, pneumomediastinum, pneumothorax and pneumoperitoneum, as well as cervical infection, seroma, hematoma, airway injury, vascular injury, need for reoperation, recurrence rate and disease persistence.

—

Secondary

Measure	Time frame
To evaluate the effectiveness of the procedure by comparing conventional thyroidectomy and transoral thyroidectomy by vestibular access regarding quality of life related to health and body image, measured by the ThyPRO-39, WHOQOL-bref, Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) questionnaires, applied at least 6 months postoperatively.	—

Countries

Brazil

Contacts

Public ContactRafael Souza

Instituto de Câncer Arnaldo Vieira de Carvalho

rafael.biomed88@gmail.com+55-11-947313689

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026