Contribution of 3D Printing in Anatomical Lung Segmentectomies.

NCT05695404 | Completed

• 1 other identifier: THOR-02-2019
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.

Conditions

Thoracic Surgery

Keywords

Segmentectomy; Thoracic surgery; 3D printed model; Mental workload; 3D reconstruction

Outcome Measures

Primary Outcomes (1)

• Surgeon's mental workload.

  measure of mental workload by the NASA-TLX score at the end of the surgery: It is a multidimensional rating scale that has six bipolar dimensions: mental demand (MD); physical demand (PD); time demand (TD); self performance (P); effort (E); and frustration (F). The dimensions thus reflect tasks (DM, PD, TD), performance (P), and behavioral factors (E and F). NASA-TLX is calculated through a self-questionnaire, using 20-point visual analogue scales anchored by very low and very high. The test provides a global load score between zero and 100 and by sub-dimensions, higher scores indicating higher mental loads of subjective perceptions.

  1 day

Secondary Outcomes (5)

• The surgeon's stress during surgery

  1 day

• Surgeon's attention to work by d2-R test

  1 day

• Surgeon's attention to work by EncephalApp Stroop test.

  1 day

• The surgeon's overall satisfaction at the end of the surgery.

  1 day

• Duration of the surgical procedure

  1 day

Study Arms (2)

The "Digital" arm

Surgeons had a virtual 3D reconstruction of the patient's pulmonary anatomy by the Visible Patient Planning (VP) software

Procedure: Segmentectomy

The "Digital+Object" arm

Surgeons had at their disposal on the operating field, in a transparent sterile bag, the 3D printed model, made from the virtual 3D VP software of the patient's lung anatomy

Procedure: Segmentectomy

Interventions

Segmentectomy PROCEDURE

Lung resection

The "Digital" arm; The "Digital+Object" arm

Eligibility Criteria

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

Study Population

all anatomic segmentectomies performed by full thoracoscopy in our department.

You may qualify if:

• all anatomic segmentectomies performed by full thoracoscopy, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

You may not qualify if:

• S6 segmentectomies
• S4+5 left bisegmentectomy
• Patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead
• Fondation de l'Avenir: collaborator
• Paris cite university, 75006 Paris, France: collaborator

Study Sites (1)

Institut Mutualiste Montsouris (thoracic surgery department)

Paris, 75014, France

Location

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Madalina Grigoroiu, dr

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 25, 2023
• Study Start: October 28, 2020
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

FR (1)