Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery
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|ClinicalTrials.gov Identifier: NCT00566839|
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : December 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Emphysema||Procedure: awake nonresectional LVRS Procedure: Nonawake resectional LVRS||Phase 2|
There is increasing scientific evidence that resectional lung volume reduction (LVR) can induce long lasting clinical improvements in selected patients with upper-lobe predominant emphysema and that clinical benefit and survival are better than those achieved with maximized medical treatment. The most widely employed surgical technique entails unilateral or bilateral staple resection of the most emphysematous lung tissue performed under general anesthesia through open or thoracoscopic approaches.
However, the type of surgical approach did not modify the considerable procedure-related morbidity, which can be mainly addressed to general anesthesia and surgical trauma deriving from resection of emphysematous lung tissue. Indeed, following resectional LVR expected mortality and pulmonary morbidity are 5.5% and 30%, respectively. Time spent for postoperative recovering is often prolonged with about 30% of patients still hospitalized or in rehabilitation facilities at 1 month and 15% still not at home 2 months after the operation. As a result, the cost-effectiveness of LVR continue to be questioned.
In recent years, the concept of nonresectional LVR is being investigated and new bronchoscopic approaches have been developed in an attempt of reducing the typical shortcomings of resectional LVR. Within the framework of the proposed nonsurgical methods which differ somewhat in physiopathologic bases and mechanism of LVR, a common denominator is that, so far, all needed general anesthesia.
We have developed an awake nonresectional LVR surgery technique, which respects the basic concepts of resectional LVR but adds some theoretical advantages and is performed under sole thoracic epidural anesthesia.
Following an initial pilot study to assess feasibility and early results, we want to analyze in a randomized fashion the perioperative morbidity and comprehensive 2-year results of thoracoscopic lung volume reduction surgery performed by the awake nonresectional or nonawake resectional surgical techniques.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Comparison of Thoracoscopic Lung Volume Reduction Surgery Performed by Resectional Surgical Technique Under General Anesthesia or by a Non-Resectional Technique in Awake Patients Under Sole Epidural Anesthesia|
|Study Start Date :||December 2002|
|Actual Study Completion Date :||October 2005|
Procedure: awake nonresectional LVRS
Thoracoscopic nonresectional lung volume reduction surgery carried out in awake patients under sole epidural anesthesia through plication of most emphysematous target areas of the lung
|Active Comparator: 2||
Procedure: Nonawake resectional LVRS
Thoracoscopic lung volume reduction surgery carried out under general anesthesia and one-lung ventilation through nonanatomic resection of the most emphysematous target areas of the lung
- mortality [ Time Frame: 3 months ]
- Hospital stay [ Time Frame: 2 months ]
- Forced expiratory volume in one second [ Time Frame: 24 months ]
- Residual volume [ Time Frame: 24 months ]
- Modified Medical research Council Dyspnea index [ Time Frame: 24 months ]
- Arterial carbon dioxide tension (mmHg) [ Time Frame: 2 days ]
- Arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) [ Time Frame: 2 days ]
- Anesthesia satisfaction score (graded from 1=unsatisfactory to 4=Excellent) [ Time Frame: 1 day (24h post-surgery) ]
- Six minute walking test distance (m) [ Time Frame: 24 months ]
- Short form 36-item quality of life physical function domain score [ Time Frame: 24 months ]
- Body mass index (Kg/m2) [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566839
|Policlinico Tor Vergata University|
|Rome, Italy, 00133|
|Principal Investigator:||Eugenio Pompeo, MD||Thoracic Surgery Division, Policlinico Tor Vergata University|
|Study Chair:||Tommaso C Mineo, MD||Thoracic Surgery Division, Policlinico Tor Vergata University|