Patient-Specific 3D Model-Assisted Preoperative Consultation for Thoracoscopic Lung Resection

Официальное название

Patient-Specific Three-Dimensional Thoracic Anatomical Model-Assisted Preoperative Consultation to Improve Shared Decision-Making in Patients Undergoing Thoracoscopic Lung Resection: A Single-Center Cluster Randomized Controlled Trial

Обзор

This study is a single-center, cluster randomized controlled trial evaluating whether lung three-dimensional model-assisted preoperative consultation can improve shared decision-making in adult patients undergoing thoracoscopic anatomical lung resection. Six attending thoracic surgeons will be randomized to provide either three-dimensional model-assisted consultation or usual preoperative consultation. Patients in the intervention group will receive consultation supported by a generic lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from routine preoperative imaging. Patients in the control group will receive usual preoperative consultation according to current clinical practice. The primary outcome is patient-perceived shared decision-making measured immediately after consultation using the 9-item Shared Decision-Making Questionnaire. Secondary outcomes include anxiety, disease- and surgery-related knowledge, communication satisfaction, health-related quality of life, decision regret, consultation duration, and postoperative outcomes within 30 days.

Вмешательства

• Поведенческое Lung three-dimensional model and reconstruction-assisted preoperative consultation
  In the intervention arm, surgeons will use a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data to support preoperative consultation. The reconstruction will be generated from clinically indicated routine imaging examinations and will be displayed dynamically on a physician workstation. The surgeon will use these tools to explain the lesion location, involved lobe or segment, planned resection extent, bronchovascular anatomy, lymph node assess
• Поведенческое Usual preoperative consultation
  Patients in the control arm will receive usual preoperative consultation according to current clinical practice. Usual consultation may include oral explanation, review of routine computed tomography images, surgical diagrams, printed materials, and discussion of diagnosis, treatment options, risks, and expected recovery. The lung three-dimensional model and dynamic three-dimensional reconstruction display will not be used.

Первичные конечные точки

• Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire [Срок оценки: Immediately after consultation]

Вторичные конечные точки (6)

• State anxiety score measured by the 6-item State-Trait Anxiety Inventory [Срок оценки: Baseline before consultation, immediately after consultation, and 7 days after surgery]
• Disease- and surgery-related knowledge score [Срок оценки: Baseline before consultation and immediately after consultation]
• Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form [Срок оценки: 7 days after surgery]
• Health-related quality of life measured by EQ-5D-5L [Срок оценки: Baseline, 7 days after surgery, and 30 days after surgery]
• Decision regret score measured by the Decision Regret Scale [Срок оценки: 7 days after surgery and 30 days after surgery]
• Consultation duration [Срок оценки: During the preoperative consultation]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• Scheduled to undergo elective thoracoscopic anatomical lung resection for suspected or confirmed lung tumors, defined as lobectomy or segmentectomy.
• The planned operation and relevant alternatives can be reasonably discussed during preoperative consultation by the attending thoracic surgeon.
• Clinically stable and able to participate in preoperative consultation.
• Able to read, understand, and complete Chinese questionnaires independently or with neutral assistance from research staff.
• Able and willing to provide written informed consent. -

Критерии исключения

• Emergency surgery.
• Planned wedge resection only, pneumonectomy, extrapleural pneumonectomy, or non-thoracoscopic open surgery at recruitment.
• Previous major ipsilateral thoracic surgery that substantially alters thoracic anatomy and may make the generic model misleading.
• Known cognitive impairment, severe psychiatric disorder, severe visual impairment, severe hearing impairment, or language barrier that prevents effective participation in consultation or questionnaire completion.
• Participation in another interventional study expected to affect preoperative anxiety, patient education, decision-making, or perioperative communication.
• Any other condition judged by the investigators to make the patient unsuitable for this study.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07686549 · TJ-IRB202605035

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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