Patient-Specific 3D Model-Assisted Preoperative Consultation for Thoracoscopic Lung Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung three-dimensional model and reconstruction-assisted preoperative consultation, Usual preoperative consultation.
- Who it may be relevant to
- Registry conditions: Lung Neoplasms, Thoracoscopic Lung Resection, Shared Decision Making, Preoperative Counseling. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Behavioral 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 - Behavioral 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.
Primary outcome measures
- Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire [Time frame: Immediately after consultation]
Secondary outcome measures (6)
- State anxiety score measured by the 6-item State-Trait Anxiety Inventory [Time frame: Baseline before consultation, immediately after consultation, and 7 days after surgery]
- Disease- and surgery-related knowledge score [Time frame: Baseline before consultation and immediately after consultation]
- Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form [Time frame: 7 days after surgery]
- Health-related quality of life measured by EQ-5D-5L [Time frame: Baseline, 7 days after surgery, and 30 days after surgery]
- Decision regret score measured by the Decision Regret Scale [Time frame: 7 days after surgery and 30 days after surgery]
- Consultation duration [Time frame: During the preoperative consultation]
Eligibility criteria
Inclusion criteria
- 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. -
Exclusion criteria
- 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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07686549 · TJ-IRB202605035