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Clinical Trials/NCT05695404
NCT05695404
Completed
Not Applicable

Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.

Institut Mutualiste Montsouris1 site in 1 country34 target enrollmentOctober 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Surgery
Sponsor
Institut Mutualiste Montsouris
Enrollment
34
Locations
1
Primary Endpoint
Surgeon's mental workload.
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, 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. We performed a prospective randomized controlled pilot trial on 2 parallel arms: * The "Digital" arm * The "Digital+Object" arm.

Registry
clinicaltrials.gov
Start Date
October 28, 2020
End Date
October 5, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Surgeon's mental workload.

Time Frame: 1 day

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.

Secondary Outcomes

  • Duration of the surgical procedure(1 day)
  • The surgeon's stress during surgery(1 day)
  • The surgeon's overall satisfaction at the end of the 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)

Study Sites (1)

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