The Fast Track Rehabilitation in Thoracic Surgery

Not Applicable

• Conditions: Thoracic Surgery
• Interventions: Behavioral: Early exercises; Behavioral: commun interventions; Behavioral: Removing urinary probe and all catheters.; Behavioral: Early alimentation

• Registration Number: NCT02831140
• Lead Sponsor: Habib Bourguiba University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-26
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-08
• Last Update Submitted: 2016-07-08
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FTR protocol group (A)	Early exercises	A. Experimental : FTR protocol group : Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting .
FTR protocol group (A)	Removing urinary probe and all catheters.	A. Experimental : FTR protocol group : Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting .
Common arm : for both groups :	commun interventions	* In preoperative phase * In peroperative phase * In postoperative phase
FTR protocol group (A)	Early alimentation	A. Experimental : FTR protocol group : Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting .

Primary Outcome Measures

Name	Time	Method
Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection	within postoperative 30 days	discharge criteria: * Chest tube removal; * Unassisted ambulation; * Afebrile without major complications; * Willing discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital; 🇹🇳 Sfax, Tunisia