Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling

Trial Title: Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling

NCT ID: NCT06276530

Condition: Resectable Lung Non-Small Cell Carcinoma

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Posture-respiratory coupling,
Robotic-assisted thoracic surgery
Conventional thoracotomy

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: EOS imaging for musculoskeletal disorder
Description: The patients will have a low radiation 2D/3D biplane imaging of the rib cage, and spine before and after surgery.
Arm group label: RATS (robotic-assisted thoracoscopic surgery)
Arm group label: Thoracotomy

Intervention type: Other
Intervention name: Movement analysis by an optoelectronic camera.
Description: Movement analysis by an optoelectronic camera before and after surgery.
Arm group label: RATS (robotic-assisted thoracoscopic surgery)
Arm group label: Thoracotomy

Intervention type: Other
Intervention name: Stabilometric measurement by strength platform
Description: Stabilometric measurement by strength platform before and after surgery.
Arm group label: RATS (robotic-assisted thoracoscopic surgery)
Arm group label: Thoracotomy

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Thoracic and Vascular Surgery Tenon University Hospital

Address:
City: Paris
Zip: 75020
Country: France

Contact:
Last name: Harry ETIENNE, M.D., PhD

Phone: +33 6 67 96 82 89
Email: h.etienne@hotmail.fr

Start date: February 2024

Completion date: March 2025

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06276530