NCT06276530

Brief Summary

This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

December 19, 2023

Last Update Submit

August 29, 2025

Conditions

Resectable Lung Non-Small Cell Carcinoma

Keywords

Posture-respiratory coupling,Robotic-assisted thoracic surgeryConventional thoracotomy

Outcome Measures

Primary Outcomes (1)

  • Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS)

    Variation between pre- and post-operative measurement

    Assessment one week before surgery and 4 weeks surgery.

Secondary Outcomes (4)

  • Width of rib cage (EOS)

    Assessment one week before surgery and 4 weeks after surgery.

  • Rib cage volume (EOS)

    Assessment one week before surgery and 4 weeks after surgery.

  • " Umbrella "angle (EOS)

    Assessment one week before surgery and 4 weeks after surgery

  • Center of Pressure displacement (Optoelectronic system)

    Assessment one week before surgery and 4 weeks after surgery

Study Arms (2)

Thoracotomy

ACTIVE COMPARATOR

The patients in this group will have a major lung resection through a conventional postero-lateral thoracotomy.

Other: EOS imaging for musculoskeletal disorderOther: Movement analysis by an optoelectronic camera.Other: Stabilometric measurement by strength platform

RATS (robotic-assisted thoracoscopic surgery)

ACTIVE COMPARATOR

The patients in this group will have a major lung resection through a minimally invasive approach by RATS.

Other: EOS imaging for musculoskeletal disorderOther: Movement analysis by an optoelectronic camera.Other: Stabilometric measurement by strength platform

Interventions

EOS imaging for musculoskeletal disorderOTHER

The patients will have a low radiation 2D/3D biplane imaging of the rib cage, and spine before and after surgery.

RATS (robotic-assisted thoracoscopic surgery)Thoracotomy
Movement analysis by an optoelectronic camera.OTHER

Movement analysis by an optoelectronic camera before and after surgery.

RATS (robotic-assisted thoracoscopic surgery)Thoracotomy
Stabilometric measurement by strength platformOTHER

Stabilometric measurement by strength platform before and after surgery.

RATS (robotic-assisted thoracoscopic surgery)Thoracotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted for major lung resection
  • Surgical approach by conventional postern-lateral thoracotomy
  • Surgical approach by minimally invasive RATS

You may not qualify if:

  • \- Extended lung resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic and Vascular Surgery Tenon University Hospital

Paris, 75020, France

RECRUITING

Related Publications (3)

  • Pujol JL, Thomas PA, Giraud P, Denis MG, Tretarre B, Roch B, Bommart S. Lung Cancer in France. J Thorac Oncol. 2021 Jan;16(1):21-29. doi: 10.1016/j.jtho.2020.09.012. No abstract available.

    PMID: 33384058BACKGROUND

  • Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available.

    PMID: 28881918BACKGROUND

  • Cerfolio RJ, Price TN, Bryant AS, Sale Bass C, Bartolucci AA. Intracostal sutures decrease the pain of thoracotomy. Ann Thorac Surg. 2003 Aug;76(2):407-11; discussion 411-2. doi: 10.1016/s0003-4975(03)00447-8.

    PMID: 12902074BACKGROUND

Study Officials

  • Harry ETIENNE, M.D., PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry ETIENNE, M.D., PhD Degree

CONTACT

06.67.96.82.89harry.etienne@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

February 26, 2024

Study Start

March 25, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

FR(1)