The Fast Track Rehabilitation in Thoracic Surgery

Study Overview
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Brief Summary
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This prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using the Fast Track Rehabilitation protocol (FTR) in comparison with the traditional postoperative care. In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.

Detailed Description
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Traditionally, patients who underwent thoracic surgery have been treated with a classical protocol which include; bed rest, ambulation prohibited for 24-48 hours and starvation for several postoperative days till the recovery of bowel. Some studies reported the efficacy of early rehabilitation protocols or FTR protocols in thoracic surgery to reduce postoperative complications and to minimize hospital stay. But these studies are few and retrospective. Prospective randomized trials focuses based on the fast track regimen or medical fast track that interest only on the medical component . This prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using FTR protocol in comparison with the traditional postoperative care. In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.

Official Title
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The Fast Track Rehabilitation in Thoracic Surgery - A Prospective Randomized Study

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Behavioral: Early exercises
* Behavioral: Removing urinary probe and all catheters.
* Behavioral: Early alimentation
* Behavioral: commun interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who have lung surgery during the study period after their consents are included. Exclusion Criteria: Patients who have bad general state are unable to move or require a wake in the resuscitation. The Patients with thoracic soft tissue surgery. patients having mediastinoscopy, surgery of the chest wall or mediastinum.

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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Common arm : for both groups :<br>In preoperative phase In peroperative phase In postoperative phase | Behavioral: commun interventions<br>* In preoperative phase: stopping smoking at least 2 weeks, hospitalization and balanced alimentation one day before the surgery. In peroperative phase : no use of benzodiazepines in the anesthesia , selective intubation , maintaining vital parameters as normal and using a mini invasive surgical approach ( video thoracoscopy , video assisted thoracoscopy , thoracotomy with preservation of the posterior muscles of the chest wall , preservation of Serratus anterior and the front part of Latissimus Dorsi ). In postoperative phase : Immediate extubation ( less than 30 minutes from the surgery end) , peridural or paravertebral or intercostal block analgesia , no use of abusive antibiotic , all analgesic drugs are permitted if there are no contraindications and physiotherapy from the 6th hour.<br>|
| Experimental: FTR protocol group (A)<br>A. Experimental : FTR protocol group : Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting . | Behavioral: Early exercises<br>* In postoperative phase: Early exercises: within the first hour ;setting a half bed position, deep breathing and coughing . In the second hour, curbing vagal malaise and performing relaxation movements. In the third hour, walking about 20 to 30 minutes.<br>Behavioral: Removing urinary probe and all catheters.<br>* In postoperative phase : Removing urinary probe and all catheters.<br>Behavioral: Early alimentation<br>* In postoperative phase :Early alimentation: in the first hour to the second hour .<br>|
| No Intervention: Control group (B)<br>Traditional, conventional care group with first get up and alimentation permission in 24 hours at the postoperative. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection | discharge criteria: Chest tube removal Unassisted ambulation Afebrile without major complications Willing discharge | within postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | score measured by the Visual Analog Scale. | in 1st hour , 2nd hour , 3rd hour , 6th hour 24th hour , 48th hour at the postoperative , within postoperative 30 days | 
| The Length of Hospital Stay |  | within postoperative 30 days | 
| Thoracic surgery postoperative Complications | During the First Admission : Prolonged bubbling | within postoperative 30 days | 
| Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema |  | within postoperative 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fast track, rehabilitation, post operative complications