Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-01-31
2018-06-30
Brief Summary
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In order to conduct this study, patients having a thoracic surgery will be randomly attributed to FTR protocol group or control group.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Common arm : for both groups :
* In preoperative phase
* In peroperative phase
* In postoperative phase
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.
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 .
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.
Removing urinary probe and all catheters.
In postoperative phase : Removing urinary probe and all catheters.
Early alimentation
In postoperative phase :Early alimentation: in the first hour to the second hour .
Control group (B)
Traditional, conventional care group with first get up and alimentation permission in 24 hours at the postoperative.
No interventions assigned to this group
Interventions
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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.
Removing urinary probe and all catheters.
In postoperative phase : Removing urinary probe and all catheters.
Early alimentation
In postoperative phase :Early alimentation: in the first hour to the second hour .
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The Patients with thoracic soft tissue surgery.
* patients having mediastinoscopy, surgery of the chest wall or mediastinum.
18 Years
80 Years
ALL
No
Sponsors
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Community medicine department -Habib Bourguiba University Hospital
UNKNOWN
Habib Bourguiba University Hospital
OTHER
Responsible Party
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Abdessalem Hentati
Thoracic surgeon
Principal Investigators
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Imed Frihka, Professor
Role: STUDY_DIRECTOR
Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital
Locations
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Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital
Sfax, , Tunisia
Countries
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Central Contacts
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References
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Muehling BM, Halter GL, Schelzig H, Meierhenrich R, Steffen P, Sunder-Plassmann L, Orend KH. Reduction of postoperative pulmonary complications after lung surgery using a fast track clinical pathway. Eur J Cardiothorac Surg. 2008 Jul;34(1):174-80. doi: 10.1016/j.ejcts.2008.04.009. Epub 2008 May 19.
Sokouti M, Aghdam BA, Golzari SE, Moghadaszadeh M. A comparative study of postoperative pulmonary complications using fast track regimen and conservative analgesic treatment: a randomized clinical trial. Tanaffos. 2011;10(3):12-9.
Padilla Alarcon J, Penalver Cuesta JC. Experience with lung resection in a fast-track surgery program. Arch Bronconeumol. 2013 Mar;49(3):89-93. doi: 10.1016/j.arbres.2012.09.011. Epub 2012 Dec 13. English, Spanish.
Das-Neves-Pereira JC, Bagan P, Coimbra-Israel AP, Grimaillof-Junior A, Cesar-Lopez G, Milanez-de-Campos JR, Riquet M, Biscegli-Jatene F. Fast-track rehabilitation for lung cancer lobectomy: a five-year experience. Eur J Cardiothorac Surg. 2009 Aug;36(2):383-91; discussion 391-2. doi: 10.1016/j.ejcts.2009.02.020. Epub 2009 Mar 26.
Other Identifiers
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FTRCCVTSFAX
Identifier Type: -
Identifier Source: org_study_id
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