Thoracic Surgery3DiLUNGNCT05695404
Contribution of 3D Printing in Anatomical Lung Segmentectomies.
An observational study of Thoracic Surgery, run by Institut Mutualiste Montsouris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Segmentectomy
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2020to 5 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all anatomic segmentectomies performed by full thoracoscopy in our department.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Mutualiste Montsouris (thoracic surgery department)
Paris, 75014
About this study
Official title: Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.
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.
Read the 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.
- Conditions
- Thoracic Surgery
- Being tested
- Segmentectomy
- Keywords
- Segmentectomy, Thoracic surgery, 3D printed model, Mental workload, 3D reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SegmentectomyProcedure or surgery
Lung resection
| Study group | Role | What they receive |
|---|---|---|
| The "Digital" arm | Surgeons had a virtual 3D reconstruction of the patient's pulmonary anatomy by the Visible Patient Planning (VP) software Receives: 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 Receives: Procedure: Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
The surgeon's stress during surgery
To assess stress, the surgeon wore a Holter device throughout the surgical procedure
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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
Measured: 1 day
Duration of the surgical procedure
calculated from the skin incision to the completion of the segmentectomy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start28 Oct 2020
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir, Paris cite university, 75006 Paris, France
- Responsible party
- Sponsor
- Investigators
- Madalina Grigoroiu, dr, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695404
- Sponsor's protocol ID
- THOR-02-2019
- Acronym
- 3DiLUNG
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.
- ClinicalTrials.gov ID
- NCT05695404
- Acronym / sponsor ID
- 3DiLUNG / THOR-02-2019
- Conditions
- Thoracic Surgery
- Keywords
- Segmentectomy, Thoracic surgery, 3D printed model, Mental workload, 3D reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir, Paris cite university, 75006 Paris, France
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The "Digital" arm | – | Procedure: SegmentectomySurgeons had a virtual 3D reconstruction of the patient's pulmonary anatomy by the Visible Patient Planning (VP) software |
| The "Digital+Object" arm | – | Procedure: SegmentectomySurgeons 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all anatomic segmentectomies performed by full thoracoscopy in our department.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SegmentectomyLung resection | Procedure or surgery | The "Digital" arm, The "Digital+Object" arm |
Primary outcome
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.
5 secondary outcomes
The surgeon's stress during surgery
Time frame: 1 day
Surgeon's attention to work by d2-R test
Time frame: 1 day
Surgeon's attention to work by EncephalApp Stroop test.
Time frame: 1 day
The surgeon's overall satisfaction at the end of the surgery.
Time frame: 1 day
Duration of the surgical procedure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madalina Grigoroiu, dr principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon's mental workload. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.