Clinical trial NCT04294108: Why in Hospital After VATS Lobectomy
Official title: Why Are Patients Still in Hospital After Video-Assisted Thoracoscopic Surgery Lobectomy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Pain, Postoperative
Postoperative Nausea and Vomiting
Infection
Air Leakage
Atrial Fibrillation
Keywords: in hospital
lobectomy
video-assisted thoracoscopic surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent VATS lobectomy and writing informed consent.

Brief summary: The study aims to identify specific or potential reasons that prolong the length of hospital stay after video-assisted thoracoscopic surgery lobectomy.

The hypothesis is that patients who are still in hospital after video-assisted thoracoscopic surgery lobectomy are associated with prolonged air leak, infection, pneumonia, atrial fibrillation or other complications or social factors.


Eligibility criteria: Inclusion Criteria:

* Patients referred to elective VATS lobectomy
* Speaks and understands Danish
* Informed consent obtained

Exclusion Criteria:

•Age \< 18 years

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: Through study completion, an average of 2 days
Secondary outcomes:
measure: Number and frequency of postoperative complications
timeFrame: Up to 30 days
measure: Numeric rating scale for postoperative pain in hospitalization
timeFrame: Through study completion, an average of 2 days
measure: Drainage duration
timeFrame: Duration from postoperative chest tube placement to potential removal, an average of 2 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lin Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, MD, DMSc
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Rene H Petersen, MD, PhD
role: STUDY_CHAIR
References:
citation: Laursen LO, Petersen RH, Hansen HJ, Jensen TK, Ravn J, Konge L. Video-assisted thoracoscopic surgery lobectomy for lung cancer is associated with a lower 30-day morbidity compared with lobectomy by thoracotomy. Eur J Cardiothorac Surg. 2016 Mar;49(3):870-5. doi: 10.1093/ejcts/ezv205. Epub 2015 Jun 18.
citation: Agostini PJ, Lugg ST, Adams K, Smith T, Kalkat MS, Rajesh PB, Steyn RS, Naidu B, Rushton A, Bishay E. Risk factors and short-term outcomes of postoperative pulmonary complications after VATS lobectomy. J Cardiothorac Surg. 2018 Apr 12;13(1):28. doi: 10.1186/s13019-018-0717-6.
citation: Kehlet H. ERAS Implementation-Time To Move Forward. Ann Surg. 2018 Jun;267(6):998-999. doi: 10.1097/SLA.0000000000002720. No abstract available.
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citation: Holbek BL, Horsleben Petersen R, Kehlet H, Hansen HJ. Fast-track video-assisted thoracoscopic surgery: future challenges. Scand Cardiovasc J. 2016;50(2):78-82. doi: 10.3109/14017431.2015.1114665. Epub 2015 Dec 1.
citation: Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
citation: Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.
citation: Munk-Madsen P, Eriksen JR, Kehlet H, Gogenur I. Why still in hospital after laparoscopic colorectal surgery within an enhanced recovery programme? Colorectal Dis. 2019 Dec;21(12):1438-1444. doi: 10.1111/codi.14762. Epub 2019 Aug 13.
citation: Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
citation: Marjanski T, Wnuk D, Bosakowski D, Szmuda T, Sawicka W, Rzyman W. Patients who do not reach a distance of 500 m during the 6-min walk test have an increased risk of postoperative complications and prolonged hospital stay after lobectomy. Eur J Cardiothorac Surg. 2015 May;47(5):e213-9. doi: 10.1093/ejcts/ezv049. Epub 2015 Feb 26.