Contribution of 3D Printing in Anatomical Lung Segmentectomies.

NCT ID: NCT05695404

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-28

Study Completion Date

2021-10-05

Brief Summary

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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

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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

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Thoracic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The "Digital" arm

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

Segmentectomy

Intervention Type PROCEDURE

Lung resection

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

Segmentectomy

Intervention Type PROCEDURE

Lung resection

Interventions

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Segmentectomy

Lung resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de l'Avenir

OTHER

Sponsor Role collaborator

Paris cite university, 75006 Paris, France

UNKNOWN

Sponsor Role collaborator

Institut Mutualiste Montsouris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madalina Grigoroiu, dr

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Locations

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Institut Mutualiste Montsouris (thoracic surgery department)

Paris, , France

Site Status

Countries

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France

Other Identifiers

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THOR-02-2019

Identifier Type: -

Identifier Source: org_study_id

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