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Clinical Trials/NCT02831140
NCT02831140
Unknown
Not Applicable

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

Habib Bourguiba University Hospital1 site in 1 country100 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Surgery
Sponsor
Habib Bourguiba University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
June 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Habib Bourguiba University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Abdessalem Hentati

Thoracic surgeon

Habib Bourguiba University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection

Time Frame: within postoperative 30 days

discharge criteria: * Chest tube removal * Unassisted ambulation * Afebrile without major complications * Willing discharge

Secondary Outcomes

  • Pain(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(within postoperative 30 days)
  • Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema(within postoperative 30 days)

Study Sites (1)

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