Clinical Study on the Efficacy of Laparoscopic Assisted Open Surgery Through Subclavian Approach for Unilateral Thyroid Cancer
Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer
This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between the two surgical procedures, and provide guidance for surgical selection and safety in the later stage.
This study is a clinical controlled trial that plans to include 400 consecutive patients with thyroid cancer. After being fully informed and signing the informed consent form, the subjects will enter the trial period after being screened and qualified. The subjects will undergo non inflatable subclavian endoscopic thyroidectomy or open subclavian thyroidectomy according to their own wishes. The enrollment period is from March 2026-2028. The follow-up period should be at least 5 years.
After the start of the experiment, a recruitment notice and corresponding recruitment manual will be issued, with a planned recruitment of 100 patients. The preparation stage for clinical research should include the preparation, distribution, and confirmation of research documents, as well as personnel training; Sign the informed consent form and screen the subjects. The surgical method for thyroid cancer is determined by the surgeon based on the patient's condition and after communication with the patient Evaluate the number of lymph nodes and metastatic lymph nodes in the central area by the pathology department, organize the operation time according to the surgical records, calculate the patient's drainage volume and hospitalization time according to the nursing records, and conduct telephone follow-up on patient satisfaction in the later stage.
Establish individual patient information using the existing thyroid cancer database in the department, recording general information, diagnosis and treatment history, and other relevant data.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Juliang Zhang
- Номер телефона: 86+18792998965
- Электронная почта: 408123913@qq.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Patients with newly diagnosed thyroid cancer aged ≥ 18 years and ≤ 70 years old;
- According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes.
- The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer;
- The surgical method is determined through joint consultation between the patient and the doctor;
- Participants voluntarily join this study and sign an informed consent form.
Exclusion Criteria:
- Age>70 years old;
- Initial diagnosis of stage III-IV thyroid cancer;
- Thyroid cancer accompanied by abnormal thyroid function;
- The heart, lung, liver, kidney and other important organs have abnormal functions, and diabetes with poor control cannot tolerate surgery;
- The researcher believes that the patient is not suitable to participate in any other circumstances of this study.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
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Endoscopic assisted surgery
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Conventional open surgery
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of complications
Временное ограничение: The observation period is at least 3 years from the start of enrollment
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The short-term complication rate of surgery in subjects includes postoperative infection, postoperative bleeding, temporary recurrent laryngeal nerve injury, superior laryngeal nerve injury, and temporary hypocalcemia or hypoparathyroidism; the long-term complication rate includes permanent recurrent laryngeal nerve injury and permanent hypocalcemia or hypoparathyroidism.
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The observation period is at least 3 years from the start of enrollment
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patient satisfaction
Временное ограничение: The assessment was conducted at 6, 12, and 24 months post-surgery
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The assessment was conducted using the Patient Scar Assessment Questionnaire (PSAQ).
This questionnaire comprises four valid subscales (totaling 29 items): Scar Appearance (10 items, scoring range 9-36), Scar-Related Self-Consciousness (6 items, scoring range 6-24), Satisfaction with Appearance (8 items, scoring range 8-32), and Satisfaction with Symptoms (5 items, scoring range 5-20).
Each item is scored using a four-point categorical response scale (1=most favorable, 4=least favorable).
A higher total score indicates more severe scar-related issues or lower satisfaction.
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The assessment was conducted at 6, 12, and 24 months post-surgery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Disease-free-survival
Временное ограничение: The observation period is at least 3 years from the start of enrollment
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The duration from the subject's enrollment to the first occurrence of recurrent disease, which includes ipsilateral lymph node recurrence, local or regional recurrence, distant recurrence, and death from any cause.
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The observation period is at least 3 years from the start of enrollment
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- XJYY-LL-FJ-029
- 82303359 (Другой номер гранта/финансирования: National Natural Science Foundation of China)
- S2021-YF-YBSF-0258 (Другой номер гранта/финансирования: Key R&D Program of Shaanxi Province)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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