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NCT Number: NCT07686549

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

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Preoperative Counseling Respiratory Tract Diseases Respiratory Tract Neoplasms Shared Decision Making Thoracic Neoplasms Thoracoscopic Lung Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Lung three-dimensional model and reconstruction-assisted preoperative consultation

Behavioral

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 assessment, potential risks, alternative options, and expected recovery. No additional imaging examination will be performed solely for the study.

Usual preoperative consultation

Behavioral

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 outcomes

  1. Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire

    Time frame: Immediately after consultation

Secondary 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 surgery

  2. Disease- and surgery-related knowledge score

    Time frame: Baseline before consultation and immediately after consultation

  3. Perioperative communication satisfaction score measured by the Patient Satisfaction Questionnaire Short Form

    Time frame: 7 days after surgery

  4. Health-related quality of life measured by EQ-5D-5L

    Time frame: Baseline, 7 days after surgery, and 30 days after surgery

  5. Decision regret score measured by the Decision Regret Scale

    Time frame: 7 days after surgery and 30 days after surgery

  6. Consultation duration

    Time frame: During the preoperative consultation

Other outcomes

  1. Observed shared decision-making during optional audio-recorded consultations measured by Observer OPTION-5

    Time frame: During the index preoperative consultation

  2. Number and type of patient and family questions during optional audio-recorded consultations

    Time frame: During the index preoperative consultation

  3. Adherence to the core consultation checklist during optional audio-recorded consultations

    Time frame: During the index preoperative consultation

  4. Postoperative complications within 30 days

    Time frame: Within 30 days after surgery

  5. Postoperative length of hospital stay

    Time frame: Perioperative

  6. Unplanned readmission within 30 days

    Time frame: Within 30 days after surgery

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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