Clinical trial NCT01268475: Exercise Capacity in Bronchiectasis Resection
Official title: Impact of Pulmonary Resection on Exercise Capacity in Patients With Bronchiectasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Quality of Life
Respiratory Function Tests
Exercise Test
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical and radiological diagnosis of bronchiectasis recruited on Pulmonary Suppurative Disease Clinic of Thoracic Surgery Department

Brief summary: Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial tree due to repeated cycles of inflammation and infection, resulting in progressive loss of lung function. The surgical treatment by pulmonary resection or even lung transplantation is indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment, or when associated with serious complications. There are few literature data on the influence of bronchiectasis in exercise capacity, quality of life and functional capacity, and the impact of lung resection in patients with this diagnosis. The primary objective of this study is to evaluate prospectively the impact of lung resection on exercise capacity in patients with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this study is to evaluate the impact of lung resection on quality of life and lung function and to analyze the the presence of predictors of postoperative functional deterioration and the occurrence of complications.


Eligibility criteria: Inclusion Criteria:

* Clinical and radiographic diagnosis of bronchiectasis;
* Lack of adequate response to clinical treatment after 1 year of follow-up and / or presence of disease complications;
* Agreement to participate of the study by signing of the Informed Consent Term

Exclusion Criteria:

* Comorbidities that prevent the patient to undergo general anesthesia;
* Musculoskeletal and/or psychomotor disability to perform pulmonary function tests and cardiopulmonary exercise tests;
* Inability to understand the quality of life questionnaires;
* Age over 90 years or less 18 years.

Primary outcomes:
measure: Impact of Pulmonary Resection on Exercise Capacity
timeFrame: Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months
Secondary outcomes:
measure: Impact of Pulmonary Resection on Quality of Life.
timeFrame: Change from Baseline in Quality of Life at 3 months and Change from Baseline in Quality of Life at 9 months.
measure: Impact of Pulmonary Resection on Lung Function.
timeFrame: Change from Baseline in Lung Function at 3 months and Change from Baseline in Lung Function at 9 months.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo Medical School - Heart Institute
Study officials:
References:
citation: Mariani AW, Vallilo CC, de Albuquerque ALP, Salge JM, Augusto MC, Suesada MM, Pego-Fernandes PM, Terra RM. Preoperative evaluation for lung resection in patients with bronchiectasis: should we rely on standard lung function evaluation? Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1272-1278. doi: 10.1093/ejcts/ezaa454.