3D Lung Reconstructions Using Open-source Software for Lung Cancer Surgery

NCT06132607 | Completed

• 2 other identifiers: Z2022177METCZ20220105
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative three-dimensional (3D) lung reconstructions can reduce intraoperative blood loss, conversion rate, and operation duration. Commercial products predominantly provide these 3D reconstructions, hence the aim of this study was to assess the usability and performance of preoperative 3D lung reconstructions created with open-source software.

Conditions

Lobectomy; Segmentectomy; Humans; Surgery; Lung Cancer; Thoracic Surgery, Video-Assisted

Keywords

video-assisted thoracoscopic surgery; lung cancer; three-dimensional reconstruction; three-dimensional simulation; open-source software

Outcome Measures

Primary Outcomes (1)

• System Usability Score

  System Usability Score Questionnaire. This questionnaire includes 10 statements rated from 1 (strongly disagree) to 5 (strongly agree). The even-numbered questions contributed to the scale position 5 minus the scale position, while the odd-numbered questions contributed to the scale position minus 1. The final score was calculated by the sum of the even and uneven-numbered questions, multiplied by 2.5. The minimum system usability score is 0 and the maximum is 100. A system usability score above 68 is considered above average.

  Single-point evaluation after surgery (at day 0)

Secondary Outcomes (5)

• Segmental lung nodule location

  Baseline and during surgery (at day 0)

• Number of arteries to target lobe or segment

  Baseline and during surgery (at day 0)

• Anatomical variations

  Baseline and during surgery (at day 0)

• Potential change of surgery or surgical plan

  Single-point evaluation after surgery (at day 0)

• Intraoperative use of 3D lung reconstruction

  Single-point evaluation after surgery (at day 0)

Study Arms (1)

Preoperative 3D lung reconstruction

Patients who were planned for an anatomical lung resection with preoperative 3D lung reconstruction from CT images

Interventions

Preoperative 3D lung reconstruction created with open-source software

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for a segmentectomy or lobectomy

You may qualify if:

• Patients with suspected or biopsy-proven lung cancer scheduled for video-assisted thoracoscopy surgery for lobectomy or segmentectomy

You may not qualify if:

• Computed Tomography scan contained motion artifacts
• Surgery was canceled
• Planned surgery changed intraoperatively to another procedure
• Patients who did not provide informed consent

Sponsors & Collaborators

• Erik de Loos: lead

Study Sites (1)

Zuyderland Medical Center

Heerlen, Limburg, 6419PC, Netherlands

Location

Related Publications (4)

• Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287-91.

  BACKGROUND

• Lewis JR, Sauro J. Item benchmarks for the system usability scale. J Usability Stud 2018;13.

  BACKGROUND

• Brooke J. SUS: a 'quick and dirty' usability. Usability Eval Ind 1996;189:189-94.

  BACKGROUND

• Laven IEWG, Oosterhoff VPS, Franssen AJPM, van Roozendaal LM, Hulsewe KWE, Vissers YLJ, de Loos ER. Evaluating three-dimensional lung reconstructions for thoracoscopic lung resections using open-source software: a pilot study. Transl Lung Cancer Res. 2024 Jul 30;13(7):1595-1608. doi: 10.21037/tlcr-24-134. Epub 2024 Jul 16.

  PMID: 39118878 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Erik de Loos, PhD

  Department of Surgery, Zuyderland Medical Center, Heerlen, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic surgeon

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 15, 2023
• Study Start: December 21, 2022
• Primary Completion: March 13, 2023
• Study Completion: April 4, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)