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NCT Number: NCT06671184

Nomogram for Predicting Difficult Transoral and Submental Thyroidectomy

No prior studies have stratified the difficulty of transoral and submental thyroidectomy (TOaST). The investigators aimed to investigate preoperative factors as indicators of difficult TOaSTs and to develop a predictive model accordingly.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location status: Recruiting

Location contact

Ling Zhan, Doctor

CONTACT

[email protected]

08615821120972

About this study

Thyroid cancer is the most common endocrine malignancy, with a female predominance. Thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. Among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. However, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. In addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. Difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. According to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. However, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. Surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. And there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm
  • Absence of suspicious lateral lymph nodes or distant metastases
  • Participants with high cosmetic expectations
  • Participants who underwent total thyroidectomy and central lymph node dissection.

Exclusion criteria

  • Participants with fusion or fixation of lymph nodes in the neck
  • Participants with history of neck surgery or radiation
  • Participants with vocal fold fixation by preoperative fibrolaryngoscope
  • Participants with preoperative examination suggestive of extrathyroidal invasion
  • Participants with a significantly restricted neck

Treatment and study plan

Observations on clinicopathological factors influencing the difficulty of surgery

Other

Age, body mass index, gender, thyroid function parameters, lesion size, lesion location, ultrasound data

Primary outcomes

  1. Number of participants with recurrent laryngeal nerve injury

    Time frame: through study completion, an average of 1 year

    impaired vocal cord mobility confirmed by postoperative laryngoscopy

  2. Number of participants with hypoparathyroidism

    Time frame: through study completion, an average of 1 year

    a postoperative parathyroid hormone level of less than 10 pg/ml

  3. Number of participants with mental nerve injury

    Time frame: through study completion, an average of 1 year

    a postoperative numbness in the lower lip and submental area

  4. operative time

    Time frame: through study completion, an average of 1 year

    operative time was defined as the duration from incision to closure, and was collected from anesthesia record sheet

Secondary outcomes

  1. hospitalization

    Time frame: through study completion, an average of 1 year

    days of hospitalization

  2. degree of pain

    Time frame: approximately 4 hours after surgery and on postoperative day 1

    pain intensity was assessed using a standard visual analogue score, with a score of 0 to 10 corresponding to no pain to the most severe pain

Study contacts

Contact information is provided by the study sponsor or research team.

Ling Zhan, Doctor

CONTACT

[email protected]

08615821120972

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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