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Completed

NCT Number: NCT05695404

Contribution of 3D Printing in Anatomical Lung Segmentectomies.

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.

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Key information

Conditions

Thoracic Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Mutualiste Montsouris (thoracic surgery department)

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Segmentectomy

Procedure

Lung resection

Primary outcomes

  1. 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

  1. The surgeon's stress during surgery

    Time frame: 1 day

    To assess stress, the surgeon wore a Holter device throughout the surgical procedure

  2. Surgeon's attention to work by d2-R test

    Time frame: 1 day

    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.

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

    Time frame: 1 day

    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.

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

    Time frame: 1 day

    To assess surgeon subjective satisfaction at the end of the surgery, we used a subjective satisfaction 5-point Likert scale

  5. Duration of the surgical procedure

    Time frame: 1 day

    calculated from the skin incision to the completion of the segmentectomy

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Collaborators

  • Fondation de l'Avenir
  • Paris cite university, 75006 Paris, France

Registry information

Official study title

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

Acronym: 3DiLUNG

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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