Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling

NCT ID: NCT06276530

Last Updated: 2025-09-02

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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In 2018, 46363 new cases of lung cancers have been diagnosed in France. It is the second most frequent cancer in men and the third most frequent cancer in women. It is the deadliest cancer in men and second deadliest cancer in women with 33117 deaths in 2018. The gold standard treatment is lobectomy with lymph node dissection in patients with a resectable tumor. The main surgical approach has long been conventional thoracotomy. It is associated with prolonged post-operative pain and discomfort because of rib spreading which injures the intercostal nerve and a costo-transverse disjunction. Moreover, in patients with narrowed intercostal space or restrictive syndrome, cher is a high risk of rib fracture associated. Alternative surgical approaches have been developed to reduce the pain and discomfort during a lobectomy. Minimally invasive approaches are mainly represented by video-assisted thoracic surgery (VATS) and robotic-assisted thoracic surgery (RATS). These approaches are characterized by the use of an endoscope during the whole procedure associated with specific instruments and the absence of rib spreading. With these technique, a similar disease-specific long-term survival is obtained compared to conventional thoracotomy. These techniques also reduce post-operative complications, post-operative acute and chronic pain and improve the quality of life. The discomfort and the decrease in quality of life comes from the pain related to the incision but could also come from the postural dysfunction , more frequent and severe after conventional thoracotomy. The physiopathology behind this postural dysfunction are not well known but seem to be related to partially to the mechanical alteration of the rib cage and partially and because of a mechanical dysfunction related to the diaphragm following the surgery. The rib cage is an important element of postural stability. The diaphragm has a key role in both breathing and posture. Alterations of these structures dedicated to stability and ventilation are potentially associated with central mechanisms which end up in an adaptation of posture-respiratory coupling. By comparing conventional thoracotomy and VATS, it has been shown that lobectomy by VATS is associated with less disruption in posture and posture-respiratory coupling compared to thoracotomy. But no data hast yet compared RATS and conventional thoracotomy. The investigators hypothesized that RATS would cause less disruption in the postural alignment, in the perception of verticality and posture-respiratory coupling index (in static position and by walking) compared to conventional thoracotomy. In this context, the investigators aim to compare the effects of conventional thoracotomy with RATS on the rib cage and the posture-respiratory coupling.

Conditions

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Resectable Lung Non-Small Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Thoracotomy

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

Group Type ACTIVE_COMPARATOR

EOS imaging for musculoskeletal disorder

Intervention Type OTHER

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

Movement analysis by an optoelectronic camera.

Intervention Type OTHER

Movement analysis by an optoelectronic camera before and after surgery.

Stabilometric measurement by strength platform

Intervention Type OTHER

Stabilometric measurement by strength platform before and after surgery.

RATS (robotic-assisted thoracoscopic surgery)

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

Group Type ACTIVE_COMPARATOR

EOS imaging for musculoskeletal disorder

Intervention Type OTHER

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

Movement analysis by an optoelectronic camera.

Intervention Type OTHER

Movement analysis by an optoelectronic camera before and after surgery.

Stabilometric measurement by strength platform

Intervention Type OTHER

Stabilometric measurement by strength platform before and after surgery.

Interventions

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EOS imaging for musculoskeletal disorder

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

Intervention Type OTHER

Movement analysis by an optoelectronic camera.

Movement analysis by an optoelectronic camera before and after surgery.

Intervention Type OTHER

Stabilometric measurement by strength platform

Stabilometric measurement by strength platform before and after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Extended lung resection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry ETIENNE, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Department of Thoracic and Vascular Surgery Tenon University Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Harry ETIENNE, M.D., PhD Degree

Role: CONTACT

06.67.96.82.89

Facility Contacts

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Harry ETIENNE, M.D., PhD

Role: primary

+33 6 67 96 82 89

References

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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.

Reference Type BACKGROUND
PMID: 33384058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28881918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12902074 (View on PubMed)

Other Identifiers

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APHP231036

Identifier Type: -

Identifier Source: org_study_id

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