Thoracic SurgeryNCT00969358
Evaluation of a Rehabilitation Program After Lung Surgery
An observational study of Thoracic Surgery, run by Hopital Foch at 1 site in France.
Trial summary
Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Dec 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- adult patient
- ASA 1, 2 or 3
- lung surgery (postero-lateral or axillary approach)
- epidural analgesia
Who cannot join
- preoperative oxygen therapy
- lack of autonomy
- unstable coronary artery disease
- FEV1 < 50%
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Rehabilitation Program After Lung Surgery (Prospective Observational Study)
Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series.
- Conditions
- Thoracic Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
length of postoperative hospital stay
Measured: end of hospitalisation
Secondary outcomes (2)
Program Monitoring
Measured: end of hospitalisation
postoperative complications
Measured: end of hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969358
- Sponsor's protocol ID
- 2009/12
- Status last verified
- Sep 2016
- First submitted
- 28 Aug 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rehabilitation Program After Lung Surgery (Prospective Observational Study)
- ClinicalTrials.gov ID
- NCT00969358
- Acronym / sponsor ID
- 2009/12
- Conditions
- Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Sep 2009 (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.
Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (4 listed)
- adult patient
- ASA 1, 2 or 3
- lung surgery (postero-lateral or axillary approach)
- epidural analgesia
Key exclusion criteria (5 listed)
- preoperative oxygen therapy
- lack of autonomy
- unstable coronary artery disease
- FEV1 < 50%
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
length of postoperative hospital stay
Time frame: end of hospitalisation
2 secondary outcomes
Program Monitoring
Time frame: end of hospitalisation
postoperative complications
Time frame: end of hospitalisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Marc Fischler, MD study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, run by Hopital Foch at 1 site in France.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Sep 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of postoperative hospital stay (time frame: end of hospitalisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2016; AzTrials last refreshed its copy on 31 Oct 2026.