Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling (VaPosVent)

February 21, 2024 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75020
        • Department of Thoracic and Vascular Surgery Tenon University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thoracotomy
The patients in this group will have a major lung resection through a conventional postero-lateral thoracotomy.
Other: 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.
Other: Movement analysis by an optoelectronic camera.
Movement analysis by an optoelectronic camera before and after surgery.
Other: Stabilometric measurement by strength platform
Stabilometric measurement by strength platform before and after surgery.
Active Comparator: RATS (robotic-assisted thoracoscopic surgery)
The patients in this group will have a major lung resection through a minimally invasive approach by RATS.
Other: 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.
Other: Movement analysis by an optoelectronic camera.
Movement analysis by an optoelectronic camera before and after surgery.
Other: Stabilometric measurement by strength platform
Stabilometric measurement by strength platform before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment one week before surgery and 4 weeks surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment one week before surgery and 4 weeks after surgery.
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
Assessment one week before surgery and 4 weeks after surgery.
" Umbrella "angle (EOS)
Time Frame: Assessment one week before surgery and 4 weeks after surgery
Variation between pre- and post-operative measurement
Assessment one week before surgery and 4 weeks after surgery
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
Assessment one week before surgery and 4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Harry ETIENNE, M.D., PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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