Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276530
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-12-19
Brief Title:
Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VaPosVent
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None