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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Juliang Zhang
- Número de telefone: 86+18792998965
- E-mail: 408123913@qq.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Endoscopic assisted surgery
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Conventional open surgery
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of complications
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Disease-free-survival
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XJYY-LL-FJ-029
- 82303359 (Número de outro subsídio/financiamento: National Natural Science Foundation of China)
- S2021-YF-YBSF-0258 (Número de outro subsídio/financiamento: Key R&D Program of Shaanxi Province)
Informações sobre medicamentos e dispositivos, documentos de estudo
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