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

3. juli 2026 opdateret af: Zhang Ni, Tongji Hospital

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

132

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

  6. Any other condition judged by the investigators to make the patient unsuitable for this study.

    -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lung 3D model and reconstruction-assisted consultation
Patients will receive usual preoperative consultation supplemented by a generic modular lung three-dimensional model and patient-specific three-dimensional reconstruction data generated from clinically indicated routine imaging examinations.
Adfærdsmæssigt: 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 assessment, potential risks, alternative options, and expected recovery. No additional imaging examination will be performed solely for the study.
Aktiv komparator: Usual preoperative consultation
Patients will receive usual preoperative consultation according to current departmental practice without structured use of the lung three-dimensional model or workstation-based dynamic three-dimensional reconstruction display.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Patient-perceived shared decision-making score measured by the 9-item Shared Decision-Making Questionnaire
Tidsramme: Immediately after consultation
Immediately after consultation

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tidsramme
Observed shared decision-making during optional audio-recorded consultations measured by Observer OPTION-5
Tidsramme: During the index preoperative consultation
During the index preoperative consultation
Number and type of patient and family questions during optional audio-recorded consultations
Tidsramme: During the index preoperative consultation
During the index preoperative consultation
Adherence to the core consultation checklist during optional audio-recorded consultations
Tidsramme: During the index preoperative consultation
During the index preoperative consultation
Postoperative complications within 30 days
Tidsramme: Within 30 days after surgery
Within 30 days after surgery
Postoperative length of hospital stay
Tidsramme: Perioperative
Perioperative
Unplanned readmission within 30 days
Tidsramme: Within 30 days after surgery
Within 30 days after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tongji Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

28. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TJ-IRB202605035

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