Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche All'Interno Del Registro Vats Group

Thoracic Surgery, Video-Assisted Clinical Trial

— VATS  

Official title:

Studio Osservazionale Retrospettivo Uneventful Vatslobectomy: Caratteristiche Cliniche

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511091
• Other study ID #: EM352-2020_AOUFe/171173_EM1
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: July 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients of the Italian VATS Group Database between January 2014 and January 2020

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• VATS lobectomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

References & Publications (26)

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Cattaneo 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. — View Citation

Daly DJ, Myles PS. Update on the role of paravertebral blocks for thoracic surgery: are they worth it? Curr Opin Anaesthesiol. 2009 Feb;22(1):38-43. doi: 10.1097/ACO.0b013e32831a4074. Review. — View Citation

Decaluwe H, Petersen RH, Hansen H, Piwkowski C, Augustin F, Brunelli A, Schmid T, Papagiannopoulos K, Moons J, Gossot D; ESTS Minimally Invasive Thoracic Surgery Interest Group (MITIG). Major intraoperative complications during video-assisted thoracoscopic anatomical lung resections: an intention-to-treat analysis. Eur J Cardiothorac Surg. 2015 Oct;48(4):588-98; discussion 599. doi: 10.1093/ejcts/ezv287. — View Citation

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Giambrone 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?†. Eur J Cardiothorac Surg. 2016 Apr;49(4):e65-71. doi: 10.1093/ejcts/ezv476. Epub 2016 Jan 27. — View Citation

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Gonfiotti 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. Review. — View Citation

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Kamiyoshihara M, Nagashima T, Ibe T, Atsumi J, Shimizu K, Takeyoshi I. Is epidural analgesia necessary after video-assisted thoracoscopic lobectomy? Asian Cardiovasc Thorac Ann. 2010 Oct;18(5):464-8. doi: 10.1177/0218492310381817. — View Citation

Magee MJ, Herbert MA, Tumey L, Prince SL. Establishing a Dedicated General Thoracic Surgery Subspecialty Program Improves Lung Cancer Outcomes. Ann Thorac Surg. 2017 Apr;103(4):1063-1069. doi: 10.1016/j.athoracsur.2016.09.033. Epub 2016 Dec 8. — View Citation

Maggino L, Liu JB, Ecker BL, Pitt HA, Vollmer CM Jr. Impact of Operative Time on Outcomes after Pancreatic Resection: A Risk-Adjusted Analysis Using the American College of Surgeons NSQIP Database. J Am Coll Surg. 2018 May;226(5):844-857.e3. doi: 10.1016/j.jamcollsurg.2018.01.004. Epub 2018 Mar 1. — View Citation

Mathisen 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. — View Citation

Osnabrugge 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. — View Citation

Otake H, Yasunaga H, Horiguchi H, Matsutani N, Matsuda S, Ohe K. Impact of hospital volume on chest tube duration, length of stay, and mortality after lobectomy. Ann Thorac Surg. 2011 Sep;92(3):1069-74. doi: 10.1016/j.athoracsur.2011.04.087. — View Citation

Park HS, Detterbeck FC, Boffa DJ, Kim AW. Impact of hospital volume of thoracoscopic lobectomy on primary lung cancer outcomes. Ann Thorac Surg. 2012 Feb;93(2):372-9. doi: 10.1016/j.athoracsur.2011.06.054. Epub 2011 Sep 25. — View Citation

Park JS, Kim HK, Choi YS, Kim J, Shim YM, Kim K. Unplanned conversion to thoracotomy during video-assisted thoracic surgery lobectomy does not compromise the surgical outcome. World J Surg. 2011 Mar;35(3):590-5. doi: 10.1007/s00268-010-0913-6. — View Citation

Paton 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. Review. — View Citation

Paul 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. — View Citation

Piccioni F, Ragazzi R. Anesthesia and analgesia: how does the role of anesthetists changes in the ERAS program for VATS lobectomy. J Vis Surg. 2018 Jan 11;4:9. doi: 10.21037/jovs.2017.12.11. eCollection 2018. — View Citation

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.

Sanchez-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. Review. — View Citation

Wright 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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to identify factors associated to short lenght of stay after VATS lobectomy	to identify factors associated to short lenght of stay after VATS lobectomy	2014-2020
Secondary	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	2014-2020