The Fast Track Rehabilitation in Thoracic Surgery

Thoracic Surgery Clinical Trial

— FTR-TS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831140
• Other study ID #: FTRCCVTSFAX
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2016
• Last updated: July 8, 2016
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2016
• Source: Habib Bourguiba University Hospital
• Contact: Ahmed Ben Ayed, Resident
• Phone: 23935354
• Email: ahmed.benayed.tunisia[@]gmail.com
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Tunisia	Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital	Sfax

Sponsors (2)

Lead Sponsor	Collaborator
Habib Bourguiba University Hospital	Community medicine department -Habib Bourguiba University Hospital

Country where clinical trial is conducted

Tunisia, 

References & Publications (4)

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):3 — View 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. — View Citation

Padilla Alarcón J, Peñalver 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection	discharge criteria: Chest tube removal; Unassisted ambulation; Afebrile without major complications; Willing discharge	within postoperative 30 days	Yes
Secondary	Pain	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	No
Secondary	The Length of Hospital Stay		within postoperative 30 days	No
Secondary	Thoracic surgery postoperative Complications	During the First Admission : Prolonged bubbling	within postoperative 30 days	Yes
Secondary	Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema		within postoperative 30 days	Yes