Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02502318
Status:
TERMINATED
Last Update Posted:
2024-01-12
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medicoeconomic Evaluation of Two Surgical Techniques for Lobectomy in the Lung Cancer
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Study Overview
Official Title:
Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of inclusions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LungSco01
Brief Summary:
This is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy.
Lobectomy may be performed in two different ways:
* Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
* By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.
The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.
This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.
Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.
Lobectomy may be performed in two different ways:
* Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
* By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.
The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.
This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.
Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: