Thoracic SurgeryFTR-TSNCT02831140
The Fast Track Rehabilitation in Thoracic Surgery
A study testing Early exercises, Removing urinary probe and all catheters. and Early alimentation in people with Thoracic Surgery, run by Habib Bourguiba University Hospital at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Early exercises, Removing urinary probe and all catheters. and Early alimentation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who have lung surgery during the study period after their consents are included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Cardiovascular and thoracic surgery department - Habib Bouguiba University Hospital
Sfax
About this study
Official title: The Fast Track Rehabilitation in Thoracic Surgery - A Prospective Randomized Study
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.
Read the 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.
- Conditions
- Thoracic Surgery
- Being tested
- Early exercises, Removing urinary probe and all catheters., Early alimentation, commun interventions
- Keywords
- Fast track, rehabilitation, post operative complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early exercisesBehavioural
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.Behavioural
In postoperative phase : Removing urinary probe and all catheters.
Early alimentationBehavioural
In postoperative phase :Early alimentation: in the first hour to the second hour .
commun interventionsBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Common arm : for both groups : | Other | * In preoperative phase
* In peroperative phase
* In postoperative phase Receives: 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 . Receives: Behavioral: Early exercises; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection
discharge criteria:
- Chest tube removal
- Unassisted ambulation
- Afebrile without major complications
- Willing discharge
Measured: within postoperative 30 days
Secondary outcomes (4)
Pain
score measured by the Visual Analog Scale.
Measured: 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
Measured: within postoperative 30 days
Thoracic surgery postoperative Complications
During the First Admission : Prolonged bubbling
Measured: within postoperative 30 days
Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema
Measured: within postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habib Bourguiba University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdessalem Hentati, Habib Bourguiba University Hospital
- Investigators
- Imed Frihka, Professor, Study director, Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831140
- Sponsor's protocol ID
- FTRCCVTSFAX
- Acronym
- FTR-TS
- Status last verified
- Jul 2016
- First submitted
- 26 May 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18490173Sokouti 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.
PubMed 25191370Padilla 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.
PubMed 23245565Das-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.
PubMed 19324571
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fast Track Rehabilitation in Thoracic Surgery - A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02831140
- Acronym / sponsor ID
- FTR-TS / FTRCCVTSFAX
- Conditions
- Thoracic Surgery
- Keywords
- Fast track, rehabilitation, post operative complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Habib Bourguiba University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Common arm : for both groups : | Other | Behavioral: commun interventions* In preoperative phase * In peroperative phase * In postoperative phase |
| FTR protocol group (A) | Experimental | Behavioral: Early exercises, Behavioral: Removing urinary probe and all catheters., Behavioral: Early alimentationA. Experimental : FTR protocol group : Early exercises after a thoracic surgery : removing urinary probe and all catheters as well as alimenting . |
| Control group (B) | No intervention | –Traditional, conventional care group with first get up and alimentation permission in 24 hours at the postoperative. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who have lung surgery during the study period after their consents are included.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early exercisesIn 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. | Behavioural | FTR protocol group (A) |
| Removing urinary probe and all catheters.In postoperative phase : Removing urinary probe and all catheters. | Behavioural | FTR protocol group (A) |
| Early alimentationIn postoperative phase :Early alimentation: in the first hour to the second hour . | Behavioural | FTR protocol group (A) |
| 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. | Behavioural | Common arm : for both groups : |
Primary outcome
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
4 secondary outcomes
Pain
Time frame: 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
Time frame: within postoperative 30 days
Thoracic surgery postoperative Complications
Time frame: within postoperative 30 days
Surgery postoperative Complications : pulmonary embolism or cardiac arrhythmia or pleural empyema
Time frame: within postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Background: PubMed 18490173Muehling 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.
- Background: PubMed 25191370Sokouti 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.
- Results publication: PubMed 23245565Padilla 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.
- Results publication: PubMed 19324571Das-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imed Frihka, Professor study director
Cardiovascular and thoracic surgery department - Habib Bourguiba University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early exercises, Removing urinary probe and all catheters. and Early alimentation in people with Thoracic Surgery, run by Habib Bourguiba University Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ben Ayed, Resident (23935354 ext. 00216, ahmed.benayed.tunisia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complications: Atelectasis or re-expansion failure or pneumonic infection (time frame: within postoperative 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831140, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.