NCT04294108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2021

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

February 27, 2020

Last Update Submit

November 2, 2021

Conditions

Carcinoma, Non-Small-Cell LungPain, PostoperativePostoperative Nausea and VomitingInfectionAir LeakageAtrial Fibrillation

Keywords

in hospitallobectomyvideo-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Length of postoperative hospital stay

    Through study completion, an average of 2 days

Secondary Outcomes (3)

  • Number and frequency of postoperative complications

    Up to 30 days

  • Numeric rating scale for postoperative pain in hospitalization

    Through study completion, an average of 2 days

  • Drainage duration

    Duration from postoperative chest tube placement to potential removal, an average of 2 days

Study Arms (1)

Patients underwent VATS lobectomy

All consecutive patients scheduled for video-assisted thoracoscopic surgery lobectomy.

Other: Prolong in-hospital stay

Interventions

Prolong in-hospital stayOTHER

Patients have a longer length of hospital stay than the common recommendation.

Patients underwent VATS lobectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent VATS lobectomy and writing informed consent.

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (11)

  • 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.

    PMID: 26088592BACKGROUND

  • 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.

    PMID: 29673386BACKGROUND

  • Kehlet H. ERAS Implementation-Time To Move Forward. Ann Surg. 2018 Jun;267(6):998-999. doi: 10.1097/SLA.0000000000002720. No abstract available.

    PMID: 29462010BACKGROUND

  • 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.

    PMID: 19324571BACKGROUND

  • 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.

    PMID: 26514281BACKGROUND

  • 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.

    PMID: 30304509BACKGROUND

  • 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.

    PMID: 22066560BACKGROUND

  • 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.

    PMID: 31309661BACKGROUND

  • 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.

    PMID: 22219442BACKGROUND

  • 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.

    PMID: 25651787BACKGROUND

  • 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.

    PMID: 25721817BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungPain, PostoperativePostoperative Nausea and VomitingInfectionsAtrial Fibrillation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomitingArrhythmias, CardiacHeart DiseasesCardiovascular Diseases

Study Officials

  • Lin Huang, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD, DMSc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

  • Rene H Petersen, MD, PhD

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor/ Research Fellow

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 3, 2020

Study Start

April 20, 2020

Primary Completion

December 18, 2020

Study Completion

September 18, 2021

Last Updated

November 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)