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NCT Number: NCT06276530

Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic and Vascular Surgery Tenon University Hospital

Paris, 75020, France

Location status: Recruiting

Location contact

Harry ETIENNE, M.D., PhD

CONTACT

[email protected]

+33 6 67 96 82 89

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

EOS imaging for musculoskeletal disorder

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.

Other

Movement analysis by an optoelectronic camera before and after surgery.

Stabilometric measurement by strength platform

Other

Stabilometric measurement by strength platform before and after surgery.

Primary outcomes

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

    Time frame: Assessment one week before surgery and 4 weeks surgery.

    Variation between pre- and post-operative measurement

Secondary outcomes

  1. Width of rib cage (EOS)

    Time frame: Assessment one week before surgery and 4 weeks after surgery.

    Variation between pre- and post-operative measurement in centimeters

  2. Rib cage volume (EOS)

    Time frame: Assessment one week before surgery and 4 weeks after surgery.

    Variation between pre- and post-operative measurement in Liter

  3. " Umbrella "angle (EOS)

    Time frame: Assessment one week before surgery and 4 weeks after surgery

    Variation between pre- and post-operative measurement

  4. Center of Pressure displacement (Optoelectronic system)

    Time frame: Assessment one week before surgery and 4 weeks after surgery

    Variation between pre- and post-operative measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Harry ETIENNE, M.D., PhD Degree

CONTACT

[email protected]

06.67.96.82.89

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: VaPosVent

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Sep 2, 2025

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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