Thoracic Surgery, Video-AssistedVATSNCT04511091
Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche All'Interno Del Registro Vats Group
An observational study of Thoracic Surgery, Video-Assisted, run by University Hospital of Ferrara.
Trial summary
Background VATS lobectomy centers face pressure to reduce hospitalization to contain costs, and some centers have sought to develop "fast-track" protocols. There are limited data to identify which patients would be appropriate for fast-tracking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Surgery, Video-Assisted
- What is being tested?
- VATS lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jul 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were divided into two subgroups depending on their reaching the targeted length of stay (≤ or > 4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤ 4 days was assessed using a stepwise multivariate logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases.
Who may be able to join
- Patients of the Italian VATS Group Database between January 2014 and January 2020
Who cannot join
- Patients not included in the Italian VATS Group Database;
- all patients with incomplete clinical, intraoperative and postoperative data and data entered from centers sporadically (less than 10 cases per year) were also excluded.
About this study
Official title: Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche
Background VATS lobectomy centers face pressure to reduce hospitalization to contain costs, and some centers have sought to develop "fast-track" protocols. There are limited data to identify which patients would be appropriate for fast-tracking.
Objective The first objective was to identify factors associated to short lenght of stay after VATS lobectomy. The second objective was to verify the influence of these variables in uncomplicated VATS lobectomy.
Methods We reviewed all thoracoscopic lobectomies for cancer operations reported to the Italian VATS Group between January 2014 and January 2020. Patient and procedural characteristics, length of stay and 30-day morbidity and mortality were reviewed. Patients were divided into two subgroups depending on their reaching the targeted length of stay (≤ or > 4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤ 4 days was assessed using a stepwise multivariate logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases.
Read the detailed description
Data source The Italian VATS Group Database is a validated, risk-adjusted, prospective, outcomes-based program with 50 participating hospitals in Italy. The VATS Group Database collects data on different variables on a standardized data form: patient demographics informations, surgical interventions, medical history, cancer staging and outcome. Patients' outcomes are reviewed and records are updated the first time at 30 days after surgery, then at 180 days. Next update is recorded at 6 months from surgery and every 6 months for the first 2 years of follow-up, and annually thereafter. The VATS Group Database implements rigorous quality assurance and safety procedures to maintain a high level of accuracy and security of data.
The study has been approved by hospital ethics committee. The current analysis was reviewed and approved for scientific merit and feasibility by the VATS Group Scientific Committee and presented at the annual VATS Group meeting.
Patient population and study design Study population consisted of patients who received intended VATS lobectomy as the primary procedure for NSCLC at VATS Group participating centres and included in the VATS Group database between January 2014 and January 2020. We excluded all patients with incomplete clinical, intraoperative and postoperative data. Data entered from centers sporadically (less than 10 cases per year) were also excluded.
In order to analyse the factors related to lenght of stay, the study design provides a comparison between two groups of patients: the first group, identified as "LOS ≤ 4" including all patient disharged within 4 days after surgery, while the second group, called "LOS > 4" including all cases discharged after the fourth postoperative day.
Covariates We compared selected clinical variables to analyse the presence of a possible association with lenght of stay: data were divided into preoperative, intraoperative and postoperative.
Furthermore, three groups were made according to the number of cases entered by the different centers and considered as a possible influential variable: group A (less than 50 cases), group B (number of cases between 51 and 100) and group C (above 100 patients).
Statistical Analysis Patient baseline demographic and comorbidity variables were analyzed using frequencies and proportions for categorical variables and means, standard deviations (SDs), medians and interquartile ranges (IQR) for continuous variables.
The comparisons between groups (LOS ≤ 4 vs LOS > 4) categories were made by the following tests: Student t-test for continuous variables with approximately normal distribution, non-parametric Wilcoxon Mann Whitney test for other numerical variables and for categorical variables Pearson's chi-square test or Fisher's exact test in the case of low-volume categories were adopted.
To investigate the factors independently associated with the hospital stay outcome we used simple logistic regression models with the variables of interest, and a simplified multiple model with a stepwise backward procedure to obtain a more parsimonious model that contained only the significant factors. Covariates of interest were patients' demographics, co- morbidities, hospital lobectomy volume , operative features, pain relief techniques, type of surcial approach. A significance level of 0.2 was required to enter the model and a level of 0.05 was required to remain in the model. Adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) were presented. All P-values are two sided with statistical significance evaluated at the 0.05 α level. All tests were performed with Stata 13.0 statistical software (Stata Corp, College Station, TX).
- Conditions
- Thoracic Surgery, Video-Assisted
- Being tested
- VATS lobectomy
- Keywords
- VATS, lobectomy, length-of-stay, hospitalization, fast-track, discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS lobectomyProcedure or surgery
VATS lobectomy allows surgeons to carry out exactly the same operation within the chest that is performed by thoracotomy, but it is done through 3-4 small incisions without rib spreading rather than the large incision with rib spreading that a thoracotomy entails. The surgeon gains his view inside the chest from a small video camera inserted through one of the small incisions, and the procedure is carried out with long instruments passed through the other small incisions.
| Study group | Role | What they receive |
|---|---|---|
| Vats Group | patients underwent planned VATS lobectomy for NSCLC from the Italian VATS Group Database (a validated, risk-adjusted, prospective, outcomes-based program with 50 participating hospitals in Italy) were included in the analysis. Receives: Procedure: VATS lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to identify factors associated to short lenght of stay after VATS lobectomy
to identify factors associated to short lenght of stay after VATS lobectomy
Measured: 2014-2020
Secondary outcomes (1)
to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy
to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy
Measured: 2014-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Jan 2014
- Primary completion1 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Thoracic Surgery, Video-AssistedStudies 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
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pio Maniscalco, University Hospital of Ferrara
- Investigators
- GIORGIO CAVALLESCO, Professor, Study director, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511091
- Sponsor's protocol ID
- EM352-2020_AOUFe/171173_EM1
- Acronym
- VATS
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Romano PHP, Ritley D. Selecting Quality and Resource Use Measures: A Decision Guide for Community Quality Collaboratives. Agency for Healthcare Research and Quality, Rockville, MD 2010 pp. 1-106.
Carey K. Measuring the hospital length of stay/readmission cost trade-off under a bundled payment mechanism. Health Econ. 2015 Jul;24(7):790-802. doi: 10.1002/hec.3061. Epub 2014 May 7.
PubMed 24803387Osnabrugge RL, Speir AM, Head SJ, Jones PG, Ailawadi G, Fonner CE, Fonner E Jr, Kappetein AP, Rich JB. Prediction of costs and length of stay in coronary artery bypass grafting. Ann Thorac Surg. 2014 Oct;98(4):1286-93. doi: 10.1016/j.athoracsur.2014.05.073. Epub 2014 Aug 7.
PubMed 25110338Wright CD, Gaissert HA, Grab JD, O'Brien SM, Peterson ED, Allen MS. Predictors of prolonged length of stay after lobectomy for lung cancer: a Society of Thoracic Surgeons General Thoracic Surgery Database risk-adjustment model. Ann Thorac Surg. 2008 Jun;85(6):1857-65; discussion 1865. doi: 10.1016/j.athoracsur.2008.03.024.
PubMed 18498784Farjah F, Lou F, Rusch VW, Rizk NP. The quality metric prolonged length of stay misses clinically important adverse events. Ann Thorac Surg. 2012 Sep;94(3):881-7; discussion 887-8. doi: 10.1016/j.athoracsur.2012.04.082. Epub 2012 Jun 27.
PubMed 22742847Cattaneo SM, Park BJ, Wilton AS, Seshan VE, Bains MS, Downey RJ, Flores RM, Rizk N, Rusch VW. Use of video-assisted thoracic surgery for lobectomy in the elderly results in fewer complications. Ann Thorac Surg. 2008 Jan;85(1):231-5; discussion 235-6. doi: 10.1016/j.athoracsur.2007.07.080.
PubMed 18154816Francis N, Kennedy RH, Ljungqvist O, Mythen MG. Manual of fast track recovery for colorectal surgery. Berlin: Springer; 2012.
Gimenez-Mila M, Klein AA, Martinez G. Design and implementation of an enhanced recovery program in thoracic surgery. J Thorac Dis. 2016 Feb;8(Suppl 1):S37-45. doi: 10.3978/j.issn.2072-1439.2015.10.71.
PubMed 26941969Gonfiotti A, Viggiano D, Voltolini L, Bertani A, Bertolaccini L, Crisci R, Droghetti A. Enhanced recovery after surgery and video-assisted thoracic surgery lobectomy: the Italian VATS Group surgical protocol. J Thorac Dis. 2018 Mar;10(Suppl 4):S564-S570. doi: 10.21037/jtd.2018.01.157.
PubMed 29629203Paton F, Chambers D, Wilson P, Eastwood A, Craig D, Fox D, Jayne D, McGinnes E. Effectiveness and implementation of enhanced recovery after surgery programmes: a rapid evidence synthesis. BMJ Open. 2014 Jul 22;4(7):e005015. doi: 10.1136/bmjopen-2014-005015.
PubMed 25052168Giambrone GP, Smith MC, Wu X, Gaber-Baylis LK, Bhat AU, Zabih R, Altorki NK, Fleischut PM, Stiles BM. Variability in length of stay after uncomplicated pulmonary lobectomy: is length of stay a quality metric or a patient metric?dagger. Eur J Cardiothorac Surg. 2016 Apr;49(4):e65-71. doi: 10.1093/ejcts/ezv476. Epub 2016 Jan 27.
PubMed 26823164Paul S, Sedrakyan A, Chiu YL, Nasar A, Port JL, Lee PC, Stiles BM, Altorki NK. Outcomes after lobectomy using thoracoscopy vs thoracotomy: a comparative effectiveness analysis utilizing the Nationwide Inpatient Sample database. Eur J Cardiothorac Surg. 2013 Apr;43(4):813-7. doi: 10.1093/ejcts/ezs428. Epub 2012 Jul 22.
PubMed 22826474Mathisen DJ. Re: Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):609-10. doi: 10.1093/ejcts/ezv167. Epub 2015 Apr 28. No abstract available.
PubMed 25920462Berrisford R, Brunelli A, Rocco G, Treasure T, Utley M; Audit and guidelines committee of the European Society of Thoracic Surgeons; European Association of Cardiothoracic Surgeons. The European Thoracic Surgery Database project: modelling the risk of in-hospital death following lung resection. Eur J Cardiothorac Surg. 2005 Aug;28(2):306-11. doi: 10.1016/j.ejcts.2005.03.047.
PubMed 16144067Sanchez-Lorente D, Navarro-Ripoll R, Guzman R, Moises J, Gimeno E, Boada M, Molins L. Prehabilitation in thoracic surgery. J Thorac Dis. 2018 Aug;10(Suppl 22):S2593-S2600. doi: 10.21037/jtd.2018.08.18.
PubMed 30345096
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche
- ClinicalTrials.gov ID
- NCT04511091
- Acronym / sponsor ID
- VATS / EM352-2020_AOUFe/171173_EM1
- Conditions
- Thoracic Surgery, Video-Assisted
- Keywords
- VATS, lobectomy, length-of-stay, hospitalization, fast-track, discharge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 12 Aug 2020 (actual)
- 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.
Background VATS lobectomy centers face pressure to reduce hospitalization to contain costs, and some centers have sought to develop "fast-track" protocols. There are limited data to identify which patients would be appropriate for fast-tracking.
Objective The first objective was to identify factors associated to short lenght of stay after VATS lobectomy. The second objective was to verify the influence of these variables in uncomplicated VATS lobectomy.
Methods We reviewed all thoracoscopic lobectomies for cancer operations reported to the Italian VATS Group between January 2014 and January 2020. Patient and procedural characteristics, length of stay and 30-day morbidity and mortality were reviewed. Patients were divided into two subgroups depending on their reaching the targeted length of stay (≤ or > 4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤ 4 days was assessed using a stepwise multivariate logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases.
Detailed description
Data source The Italian VATS Group Database is a validated, risk-adjusted, prospective, outcomes-based program with 50 participating hospitals in Italy. The VATS Group Database collects data on different variables on a standardized data form: patient demographics informations, surgical interventions, medical history, cancer staging and outcome. Patients' outcomes are reviewed and records are updated the first time at 30 days after surgery, then at 180 days. Next update is recorded at 6 months from surgery and every 6 months for the first 2 years of follow-up, and annually thereafter. The VATS Group Database implements rigorous quality assurance and safety procedures to maintain a high level of accuracy and security of data.
The study has been approved by hospital ethics committee. The current analysis was reviewed and approved for scientific merit and feasibility by the VATS Group Scientific Committee and presented at the annual VATS Group meeting.
Patient population and study design Study population consisted of patients who received intended VATS lobectomy as the primary procedure for NSCLC at VATS Group participating centres and included in the VATS Group database between January 2014 and January 2020. We excluded all patients with incomplete clinical, intraoperative and postoperative data. Data entered from centers sporadically (less than 10 cases per year) were also excluded.
In order to analyse the factors related to lenght of stay, the study design provides a comparison between two groups of patients: the first group, identified as "LOS ≤ 4" including all patient disharged within 4 days after surgery, while the second group, called "LOS > 4" including all cases discharged after the fourth postoperative day.
Covariates We compared selected clinical variables to analyse the presence of a possible association with lenght of stay: data were divided into preoperative, intraoperative and postoperative.
Furthermore, three groups were made according to the number of cases entered by the different centers and considered as a possible influential variable: group A (less than 50 cases), group B (number of cases between 51 and 100) and group C (above 100 patients).
Statistical Analysis Patient baseline demographic and comorbidity variables were analyzed using frequencies and proportions for categorical variables and means, standard deviations (SDs), medians and interquartile ranges (IQR) for continuous variables.
The comparisons between groups (LOS ≤ 4 vs LOS > 4) categories were made by the following tests: Student t-test for continuous variables with approximately normal distribution, non-parametric Wilcoxon Mann Whitney test for other numerical variables and for categorical variables Pearson's chi-square test or Fisher's exact test in the case of low-volume categories were adopted.
To investigate the factors independently associated with the hospital stay outcome we used simple logistic regression models with the variables of interest, and a simplified multiple model with a stepwise backward procedure to obtain a more parsimonious model that contained only the significant factors. Covariates of interest were patients' demographics, co- morbidities, hospital lobectomy volume , operative features, pain relief techniques, type of surcial approach. A significance level of 0.2 was required to enter the model and a level of 0.05 was required to remain in the model. Adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) were presented. All P-values are two sided with statistical significance evaluated at the 0.05 α level. All tests were performed with Stata 13.0 statistical software (Stata Corp, College Station, TX).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vats Group | – | Procedure: VATS lobectomypatients underwent planned VATS lobectomy for NSCLC from the Italian VATS Group Database (a validated, risk-adjusted, prospective, outcomes-based program with 50 participating hospitals in Italy) were included in the analysis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were divided into two subgroups depending on their reaching the targeted length of stay (≤ or > 4 days). The association between preoperative and intraoperative variables and postoperative length of stay (LOS) ≤ 4 days was assessed using a stepwise multivariate logistic regression analysis to identify factors independently associated with LOS and factors related to LOS in uncomplicated cases.
Key inclusion criteria (1 listed)
- Patients of the Italian VATS Group Database between January 2014 and January 2020
Key exclusion criteria (2 listed)
- Patients not included in the Italian VATS Group Database;
- all patients with incomplete clinical, intraoperative and postoperative data and data entered from centers sporadically (less than 10 cases per year) were also excluded.
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 |
|---|---|---|
| VATS lobectomyVATS lobectomy allows surgeons to carry out exactly the same operation within the chest that is performed by thoracotomy, but it is done through 3-4 small incisions without rib spreading rather than the large incision with rib spreading that a thoracotomy entails. The surgeon gains his view inside the chest from a small video camera inserted through one of the small incisions, and the procedure is carried out with long instruments passed through the other small incisions. | Procedure or surgery | Vats Group |
Primary outcome
to identify factors associated to short lenght of stay after VATS lobectomy
Time frame: 2014-2020
to identify factors associated to short lenght of stay after VATS lobectomy
1 secondary outcome
to verify the influence of these variables (factors associated to short lenght of stay) in uncomplicated VATS lobectomy
Time frame: 2014-2020
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 12 Aug 2020.
- BackgroundRomano PHP, Ritley D. Selecting Quality and Resource Use Measures: A Decision Guide for Community Quality Collaboratives. Agency for Healthcare Research and Quality, Rockville, MD 2010 pp. 1-106.
- Background: PubMed 24803387Carey K. Measuring the hospital length of stay/readmission cost trade-off under a bundled payment mechanism. Health Econ. 2015 Jul;24(7):790-802. doi: 10.1002/hec.3061. Epub 2014 May 7.
- Background: PubMed 25110338Osnabrugge RL, Speir AM, Head SJ, Jones PG, Ailawadi G, Fonner CE, Fonner E Jr, Kappetein AP, Rich JB. Prediction of costs and length of stay in coronary artery bypass grafting. Ann Thorac Surg. 2014 Oct;98(4):1286-93. doi: 10.1016/j.athoracsur.2014.05.073. Epub 2014 Aug 7.
- Background: PubMed 18498784Wright CD, Gaissert HA, Grab JD, O'Brien SM, Peterson ED, Allen MS. Predictors of prolonged length of stay after lobectomy for lung cancer: a Society of Thoracic Surgeons General Thoracic Surgery Database risk-adjustment model. Ann Thorac Surg. 2008 Jun;85(6):1857-65; discussion 1865. doi: 10.1016/j.athoracsur.2008.03.024.
- Background: PubMed 22742847Farjah F, Lou F, Rusch VW, Rizk NP. The quality metric prolonged length of stay misses clinically important adverse events. Ann Thorac Surg. 2012 Sep;94(3):881-7; discussion 887-8. doi: 10.1016/j.athoracsur.2012.04.082. Epub 2012 Jun 27.
- Background: PubMed 18154816Cattaneo SM, Park BJ, Wilton AS, Seshan VE, Bains MS, Downey RJ, Flores RM, Rizk N, Rusch VW. Use of video-assisted thoracic surgery for lobectomy in the elderly results in fewer complications. Ann Thorac Surg. 2008 Jan;85(1):231-5; discussion 235-6. doi: 10.1016/j.athoracsur.2007.07.080.
- BackgroundFrancis N, Kennedy RH, Ljungqvist O, Mythen MG. Manual of fast track recovery for colorectal surgery. Berlin: Springer; 2012.
- Background: PubMed 26941969Gimenez-Mila M, Klein AA, Martinez G. Design and implementation of an enhanced recovery program in thoracic surgery. J Thorac Dis. 2016 Feb;8(Suppl 1):S37-45. doi: 10.3978/j.issn.2072-1439.2015.10.71.
- Background: PubMed 29629203Gonfiotti A, Viggiano D, Voltolini L, Bertani A, Bertolaccini L, Crisci R, Droghetti A. Enhanced recovery after surgery and video-assisted thoracic surgery lobectomy: the Italian VATS Group surgical protocol. J Thorac Dis. 2018 Mar;10(Suppl 4):S564-S570. doi: 10.21037/jtd.2018.01.157.
- Background: PubMed 25052168Paton F, Chambers D, Wilson P, Eastwood A, Craig D, Fox D, Jayne D, McGinnes E. Effectiveness and implementation of enhanced recovery after surgery programmes: a rapid evidence synthesis. BMJ Open. 2014 Jul 22;4(7):e005015. doi: 10.1136/bmjopen-2014-005015.
- Background: PubMed 26823164Giambrone GP, Smith MC, Wu X, Gaber-Baylis LK, Bhat AU, Zabih R, Altorki NK, Fleischut PM, Stiles BM. Variability in length of stay after uncomplicated pulmonary lobectomy: is length of stay a quality metric or a patient metric?dagger. Eur J Cardiothorac Surg. 2016 Apr;49(4):e65-71. doi: 10.1093/ejcts/ezv476. Epub 2016 Jan 27.
- Background: PubMed 22826474Paul S, Sedrakyan A, Chiu YL, Nasar A, Port JL, Lee PC, Stiles BM, Altorki NK. Outcomes after lobectomy using thoracoscopy vs thoracotomy: a comparative effectiveness analysis utilizing the Nationwide Inpatient Sample database. Eur J Cardiothorac Surg. 2013 Apr;43(4):813-7. doi: 10.1093/ejcts/ezs428. Epub 2012 Jul 22.
- Individual participant dataSharing planned: Undecided
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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.
GIORGIO CAVALLESCO, Professor study director
Università degli Studi di Ferrara
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, Video-Assisted, run by University Hospital of Ferrara.
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 2 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
to identify factors associated to short lenght of stay after VATS lobectomy (time frame: 2014-2020). 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 NCT04511091, which also lists 26 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 12 Aug 2020.