Evaluation of Preoperative Physiotherapy Influence on Postoperative Pulmonary Function of Megaesophagus Surgery

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2013
INTERVENTION: Device E02.880 H02.010.625 Thirty patients with megaesophagus, graus III and IV, from Clinicas Hospital of Federal University of Triangulo Mineiro and thirty patients with resectable esophageal cancer from Pio XII Foundation of Barretos Hospital of Cancer in the preoperative of esophagectomy, of both genders, aging between 18 and 75 years old will participate in the study. The patients are going to be randomly allocated in two groups (groups 1 and 2). Randomization will be stratified by gender, therefore there will be two envelopes, each with blocks of four (two per group). Group 1 (control): The volunteers are going to receive usual physical therapy care characterized by being instructed to perform deep breathing exercises associated to upper and lower limbs movements. Group 2 (intervention): The volunteers are going to receive the same treatment as group 1 and they will also perform inspiratory and expiratory muscle training with Threshold IMT and Threshold PEP devices, respectively. The preoperative physiotherapy treatment will be applied at least two weeks before surgery. One limitation of the study is that it is an open trial. CONDITION: Chagasic megaesophagus, achalasia, esophageal neoplasia. ; K23.1 ; K22.0 ; C15 PRIMARY OUTCOME: We expect that group 2 (intervention), due to the effective preoperative respiratory muscle training, evolve with lower incidence of postoperative pulmonary complications after esophageal surgery, characterized by: better pulmonary function evaluated by spirometry (higher forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio, higher maximal respiratory pressures and higher maximal voluntary ventilation evaluated with manovacuometry. SECONDARY OUTCOME: If group 2 present a better pulmonary function in the postoperative, it is possible that these patients have a shorter hospital length of stay (in days). It is possible that a better pulmonary function in the postoperative in group 2 will lead to a better functional capacity, which will be evaluated by the distance walked in the 6‐min walk test. INCLUSION CRITERIA: Patients diagnosed with achalasia grades III and IV. Patients with resectable esophageal cancer. Age greater than 18 and less than or equal to 75.
Epistemonikos ID: b41ac89275841bbc10373560c8703c06c03330ec
First added on: Aug 22, 2024