Patient-Specific 3D Model-Assisted Preoperative Consultation for Thoracoscopic Lung Resection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lung three-dimensional model and reconstruction-assisted preoperative consultation
BehavioralIn 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 assessment, potential risks, alternative options, and expected recovery. No additional imaging examination will be performed solely for the study.
Usual preoperative consultation
BehavioralPatients 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.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Lung 3D model and reconstruction-assisted consultationExperimental treatment 1 intervention
Group B: Usual preoperative consultationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire
Time frame
Immediately after consultationSecondary outcomes
1
State anxiety score measured by the 6-item State-Trait Anxiety Inventory
Time frame
Baseline before consultation, immediately after consultation, and 7 days after surgery2
Disease- and surgery-related knowledge score
Time frame
Baseline before consultation and immediately after consultation3
Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form
Time frame
7 days after surgery4
Health-related quality of life measured by EQ-5D-5L
Time frame
Baseline, 7 days after surgery, and 30 days after surgeryOther outcomes
1
Observed shared decision-making during optional audio-recorded consultations measured by Observer OPTION-5
Time frame
During the index preoperative consultation2
Number and type of patient and family questions during optional audio-recorded consultations
Time frame
During the index preoperative consultation3
Adherence to the core consultation checklist during optional audio-recorded consultations
Time frame
During the index preoperative consultation4
Postoperative complications within 30 days
Time frame
Within 30 days after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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