The Fast Track Rehabilitation in Thoracic Surgery (FTR-TS)

July 8, 2016 updated by: Abdessalem Hentati, Habib Bourguiba University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Sfax, Tunisia
        • Recruiting
        • Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Common arm : for both groups :
  • In preoperative phase
  • In peroperative phase
  • In postoperative phase
Behavioral: commun interventions
  • 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.
EXPERIMENTAL: FTR protocol group (A)

A. Experimental : FTR protocol group :

Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting .
Behavioral: Early exercises

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.

Behavioral: Removing urinary probe and all catheters.
In postoperative phase : Removing urinary probe and all catheters.
Behavioral: Early alimentation
In postoperative phase :Early alimentation: in the first hour to the second hour .
NO_INTERVENTION: Control group (B)
Traditional, conventional care group with first get up and alimentation permission in 24 hours at the postoperative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 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.
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
Time Frame: within postoperative 30 days
within postoperative 30 days
Thoracic surgery postoperative Complications
Time Frame: within postoperative 30 days
During the First Admission : Prolonged bubbling
within postoperative 30 days
Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema
Time Frame: within postoperative 30 days
within postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Habib Bourguiba University Hospital

Collaborators

Community medicine department -Habib Bourguiba University Hospital

Investigators

  • Study Director: Imed Frihka, Professor, Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTRCCVTSFAX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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