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

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ClinicalTrials.gov Identifier: NCT02831140
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
Community medicine department -Habib Bourguiba University Hospital
Information provided by (Responsible Party):
Abdessalem Hentati, 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.


Condition or disease Intervention/treatment Phase
Thoracic Surgery Behavioral: Early exercises Behavioral: Removing urinary probe and all catheters. Behavioral: Early alimentation Behavioral: commun interventions Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Fast Track Rehabilitation in Thoracic Surgery - A Prospective Randomized Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. The Length of Hospital Stay [ Time Frame: within postoperative 30 days ]
  3. Thoracic surgery postoperative Complications [ Time Frame: within postoperative 30 days ]
    During the First Admission : Prolonged bubbling

  4. Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema [ Time Frame: within postoperative 30 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831140


Contacts
Contact: Ahmed Ben Ayed, Resident 23935354 ext 00216 ahmed.benayed.tunisia@gmail.com

Locations
Tunisia
Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital Recruiting
Sfax, Tunisia
Sponsors and Collaborators
Habib Bourguiba University Hospital
Community medicine department -Habib Bourguiba University Hospital
Investigators
Study Director: Imed Frihka, Professor Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital

Publications of Results:
Other Publications:
Responsible Party: Abdessalem Hentati, Thoracic surgeon, Habib Bourguiba University Hospital
ClinicalTrials.gov Identifier: NCT02831140     History of Changes
Other Study ID Numbers: FTRCCVTSFAX
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Abdessalem Hentati, Habib Bourguiba University Hospital:
Fast track
rehabilitation
post operative complications