Why in Hospital After VATS Lobectomy

Atrial Fibrillation Clinical Trial

Official title:

Why Are Patients Still in Hospital After Video-Assisted Thoracoscopic Surgery Lobectomy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294108
• Other study ID #: H-20014489
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: September 18, 2021

Study information

• Verified date: November 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 18, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred to elective VATS lobectomy

• Speaks and understands Danish

• Informed consent obtained

Exclusion Criteria:

•Age < 18 years

Related Conditions & MeSH terms

• Air Leakage
• Atrial Fibrillation
• Carcinoma, Non-Small-Cell Lung
• Infection
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Prolong in-hospital stay
Patients have a longer length of hospital stay than the common recommendation.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

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. — View 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®) 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. Review. — View Citation

Das-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. — View 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. Review. — View 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. — View Citation

Kehlet H. ERAS Implementation-Time To Move Forward. Ann Surg. 2018 Jun;267(6):998-999. doi: 10.1097/SLA.0000000000002720. — View Citation

Laursen LØ, 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. — View 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. — View Citation

Munk-Madsen P, Eriksen JR, Kehlet H, Gögenur 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. — View 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. — View Citation

Wildgaard K, Petersen RH, Hansen HJ, Møller-Sørensen 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of postoperative hospital stay		Through study completion, an average of 2 days
Secondary	Number and frequency of postoperative complications		Up to 30 days
Secondary	Numeric rating scale for postoperative pain in hospitalization	Patients are scored using a numeric rating scale ranging from 0 (no pain) to 10 (excruciating pain) per day.	Through study completion, an average of 2 days
Secondary	Drainage duration	The criteria of drain removal is that air leak was consistently below 20 ml/min for at least 12 hours and fluid production was non-bloody and non-chylous without an upper volume limit.	Duration from postoperative chest tube placement to potential removal, an average of 2 days