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NCT Number: NCT06738888

Renovated Prediction Model for Difficult Transoral and Submental Endoscopic Thyroidectomy

The investigators have previously proposed a prediction model for difficult transoral and submental thyroidectomy through a retrospective study. In order to better promote transoral and submental endoscopic approach for thyroid surgery and to set up an appropriate training course, the investigators aim to refine the procedure through a prospective study.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location status: Recruiting

Location contact

Ling Zhan, Doctor

CONTACT

[email protected]

08615821120972

About this study

This study is a prospectively registered cohort study evaluating postoperative neck functional recovery after TOaST. As a procedure refinement, the study will further evaluate whether partial preservation of the caudal linea alba cervicalis during TOaST is associated with improved postoperative neck functional recovery without compromising surgical exposure or central compartment dissection.

The main purpose of this technical refinement is to determine whether preserving the caudal anterior cervical fascial continuity may reduce postoperative anterior neck tightness, swallowing-related traction discomfort, pain, and limitation of neck range of motion. Surgical feasibility and safety will be assessed using operative time, intraoperative blood loss, drainage volume, number of central lymph nodes retrieved, recurrent laryngeal nerve events, parathyroid-related outcomes, postoperative complications, and the rate of technical conversion.

In addition, male sex, age, BMI, neck length and certain thyroid disease such as thyroiditis and hyperthyroidism have been long cited as indicators of a difficult TOaST. The investiagtors hypothesized that neck extension was critical to the exposure and visualization of the surgical field in the endoscopic thyroidectomy. Therefore, several measurements were innovatedly integrated into the prediction model, including neck circumference, thyromental distance, sternomental distance, ratio of height-to-thyromental distance, ratio of height-to-sternomental distance.

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
  • Clinical diagnosis of benign thyroid nodule with a maximum diameter not exceeding 6 cm
  • Absence of suspicious lateral lymph nodes or distant metastases

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 and/or jaw

Treatment and study plan

Modified TOaST with caudal linea alba preservation

Procedure

The modified procedure consists of cranial limited opening of the linea alba cervicalis with intentional preservation of the caudal linea alba-strap muscle fascial bridge. Bilateral symmetric suspension of the strap muscles is performed to maintain a centered operative window for thyroid lobectomy and, when indicated, ipsilateral central compartment lymph node dissection. If exposure is inadequate, the caudal linea alba may be further opened for safety.

Primary outcomes

  1. Postoperative neck functional recovery at 1 month

    Time frame: 1 month after surgery

    Postoperative neck functional recovery will be assessed 1 month after surgery using a standardized neck function assessment, including neck discomfort, anterior neck tightness, swallowing-related traction discomfort, and neck range of motion. Higher impairment scores indicate worse neck functional recovery.

  2. Anterior neck tightness score

    Time frame: Postoperative 1 week, 1 month, and 3 months

    Anterior neck tightness will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe tightness.

  3. Swallowing-related traction discomfort

    Time frame: Postoperative 1 week, 1 month, and 3 months

    Swallowing-related traction discomfort will be assessed using a patient-reported visual analog scale or numerical rating scale. Higher scores indicate more severe discomfort.

Secondary outcomes

  1. hospitalization

    Time frame: Length of stay from hospitalisation to discharge

    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

  3. 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

  4. 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

  5. Operative time

    Time frame: Immediately at the end of the surgery

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

  6. Central compartment lymph node yield

    Time frame: At the time of pathological assessment after surgery

    For participants undergoing central compartment lymph node dissection, the number of retrieved central compartment lymph nodes will be recorded and compared between groups.

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

Official study title

A Functional-oriented Modification of TOaST Based on Partial Preservation of the Lines Alba Cervical

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 18, 2024
Registry last updated
Aug 10, 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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