NCT02831140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

May 26, 2016

Last Update Submit

July 8, 2016

Conditions

Thoracic Surgery

Keywords

Fast trackrehabilitationpost operative complications

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Pain

    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

    within postoperative 30 days

  • Thoracic surgery postoperative Complications

    within postoperative 30 days

  • Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema

    within postoperative 30 days

Study Arms (3)

Common arm : for both groups :

OTHER

* In preoperative phase * In peroperative phase * In postoperative phase

Behavioral: commun interventions

FTR protocol group (A)

EXPERIMENTAL

A. Experimental : FTR protocol group : Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting .

Behavioral: Early exercisesBehavioral: Removing urinary probe and all catheters.Behavioral: Early alimentation

Control group (B)

NO INTERVENTION

Traditional, conventional care group with first get up and alimentation permission in 24 hours at the postoperative.

Interventions

Early exercisesBEHAVIORAL

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.

FTR protocol group (A)
Removing urinary probe and all catheters.BEHAVIORAL

In postoperative phase : Removing urinary probe and all catheters.

FTR protocol group (A)
Early alimentationBEHAVIORAL

In postoperative phase :Early alimentation: in the first hour to the second hour .

FTR protocol group (A)
commun interventionsBEHAVIORAL

* 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.

Common arm : for both groups :

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who have lung surgery during the study period after their consents are included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital

Sfax, Tunisia

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18490173BACKGROUND

  • 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.

    PMID: 25191370BACKGROUND

  • 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.

    PMID: 23245565RESULT

  • 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.

    PMID: 19324571RESULT

Study Officials

  • Imed Frihka, Professor

    Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital

    STUDY DIRECTOR

Central Study Contacts

Ahmed Ben Ayed, Resident

CONTACT

23935354ahmed.benayed.tunisia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thoracic surgeon

Study Record Dates

First Submitted

May 26, 2016

First Posted

July 13, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

July 13, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)