Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care

Study Overview
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Brief Summary
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The aim of this study was to compare the functional capacity of exercise by six-minute walk test before and after thoracic surgical procedure in subjects who have undergone the Fast-track protocol with those who were under conventional care. Researchers want to find out if Fast-track is a strategy to enhance functional capacity after thoracic surgery.

Detailed Description
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Fast track programs represents a new approach to the management of patients undergoing surgery. It is perioperative care pathway designed to achieve early recovery and helps to minimize postoperative morbidity and mortality. These multimodal approaches focuses on enhancing recovery and reducing of surgical stress by minimal invasive surgery, optimized pain relief, early nutrition and ambulation. In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity. However, information on the results of Fast-track protocols in functional capacity of exercise during hospital stay is sparse. The six-minute walk test is use to measure of functional capacity of exercise in different populations and to detect changes after interventions. The distances traveled in two six-minute walk test (preoperative and postoperative) will be compared between the two groups (Fast-track and Conventional). In this trial the investigators will consider Fast-track protocol to be feasible to enhance functional capacity of exercise after thoracic surgery.

Official Title
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Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Other: Fast-track protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are scheduled to undergo a thoracic surgical procedure sign the informed consent form independent ambulation ability to understand and follow instructions Exclusion Criteria: contraindications for epidural catheter placement refusal to do physical exercises on postoperative

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fast-track protocol<br>Before surgery, patients are informed about the surgical procedure, anesthesia and rehabilitation protocol. The surgery occurs in accordance with the principles of the Fast-track: minimal invasive surgery, epidural anesthetic management, avoiding the need opioid in postoperatory analgesia and use of an standardized postoperatory management protocol to an early oral intake and early mobilization. | Other: Fast-track protocol<br>* Preoperatory management, epidural anesthetic management, avoiding the need opioid in postoperatory analgesia and use of an standardized postoperatory management protocol to an early oral intake and early mobilization. At the postoperative recovery room, after extubation and fully awake, patients started physiotherapy exercises, as physical exercises of moving up upper and lower extremities accompanied by deep breathing exercises. After than, the patients standed up beside the bed and if there was no complications, patients performed ambulation. The physiotherapist aided the patients during all period.<br>* Other names: Early rehabilitation;|
| No Intervention: Conventional care<br>Usual care routine postoperative | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity of exercise ( six-minute walk test) | Change from baseline in distance walking on hospital discharge | participants will be followed for the duration of hospital stay, an expected average of 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first postoperative ambulation | Time from end of surgical procedure until first postoperative ambulation | up 2 hour after surgery | 
| The length of hospital stay | Time to achieve standardized hospital discharge criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self care and no evidence of complications or untreated medical problems). | expected average of 6 days | 
| Surgical complications | Pneumonia, atelectasis, pneumothorax and air leak in the chest drainage | up 6 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative care, exercise test, early ambulation, Fast-track