Clinical trial NCT02831140: The Fast Track Rehabilitation in Thoracic Surgery
Official title: The Fast Track Rehabilitation in Thoracic Surgery - A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery
Keywords: Fast track
rehabilitation
post operative complications
Lead sponsor: Habib Bourguiba University Hospital
Sponsor class: OTHER
Collaborators: name: Community medicine department -Habib Bourguiba University Hospital
First posted: 2016-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection
timeFrame: within postoperative 30 days
Secondary outcomes:
measure: Pain
timeFrame: in 1st hour , 2nd hour , 3rd hour , 6th hour 24th hour , 48th hour at the postoperative , within postoperative 30 days
measure: The Length of Hospital Stay
timeFrame: within postoperative 30 days
measure: Thoracic surgery postoperative Complications
timeFrame: within postoperative 30 days
measure: Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema
timeFrame: within postoperative 30 days
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital
Study officials:
affiliation: Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital
name: Imed Frihka, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.