Contribution of 3D Printing in Anatomical Lung Segmentectomies.

Thoracic Surgery Clinical Trial

— 3DiLUNG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05695404
• Other study ID #: THOR-02-2019
• Status: Completed
• Start date: October 28, 2020
• Est. completion date: October 5, 2021

Study information

• Verified date: January 2023
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Procedure:
• Segmentectomy
Lung resection

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris (thoracic surgery department)	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Fondation de l'Avenir, Paris cite university, 75006 Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The surgeon's stress during surgery	To assess stress, the surgeon wore a Holter device throughout the surgical procedure	1 day
Secondary	Surgeon's attention to work by d2-R test	For the evaluation of the surgeon's attention to work at the end of the surgery, we used first d2-R test.; Scoring of the d2-R test included the following: concentration performance (CC), which represents the capacity of concentration; total number of target items processed, included the omitted ones (CCT), which informs about the speed of processing the test; percentage of errors (E%) which is defined as (total number of errors x 100)/CCT, and reflects performance accuracy.; These scores are standardized to standard score (NS), used by default for the computerized d2-R. The NS ranges from 20 to 80, with an average of 50. In the normal distribution scale of the d2-R test, 7% of the normative subjects scored under 35, 24% scored between 35 and 44, 38% scored between 45 and 55, 24% scored from 56 to 65 and 7% scored over 65. The scores are consider very weak, weak, mean, high and very high, respectively.	1 day
Secondary	Surgeon's attention to work by EncephalApp Stroop test.	For the evaluation of the surgeon's attention to work at the end of the surgery, we used also EncephalApp Stroop test.; The task has two components: "off" and "on" states. In the "off " state, the surgeon views a pound signs (###) presented in red, green, or blue, one at a time and has to respond as quickly as possible by touching the matching color of the stimulus to the colors displayed at the bottom of the screen. In the "on" state the subject has to accurately select the color of the word presented, which is actually the name of the color in discordant coloring. The specific outcomes of the EncephalApp Stroop test were: the total time for five correct runs in the "off " state (OffTime) and in the "on" state (OnTime); the number of runs needed to complete the five correct "off" runs and five correct "on" runs.	1 day
Secondary	The surgeon's overall satisfaction at the end of the surgery.	To assess surgeon subjective satisfaction at the end of the surgery, we used a subjective satisfaction 5-point Likert scale	1 day
Secondary	Duration of the surgical procedure	calculated from the skin incision to the completion of the segmentectomy	1 day