Carcinoma, Non-Small-Cell LungNCT04294108
Why in Hospital After VATS Lobectomy
An observational study of Carcinoma, Non-Small-Cell Lung and Pain, Postoperative, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Pain, Postoperative, Postoperative Nausea and Vomiting
- What is being tested?
- Prolong in-hospital stay
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2020to 18 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent VATS lobectomy and writing informed consent.
Who may be able to join
- Patients referred to elective VATS lobectomy
- Speaks and understands Danish
- Informed consent obtained
Who cannot join
- •Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Why Are Patients Still in Hospital After Video-Assisted Thoracoscopic Surgery Lobectomy?
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Pain, Postoperative, Postoperative Nausea and Vomiting, Infection, Air Leakage, Atrial Fibrillation
- Being tested
- Prolong in-hospital stay
- Keywords
- in hospital, lobectomy, video-assisted thoracoscopic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pain, Postoperative, Postoperative Nausea and Vomiting, Infections, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolong in-hospital stayOther
Patients have a longer length of hospital stay than the common recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent VATS lobectomy | All consecutive patients scheduled for video-assisted thoracoscopic surgery lobectomy. Receives: Other: Prolong in-hospital stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of postoperative hospital stay
Measured: Through study completion, an average of 2 days
Secondary outcomes (3)
Number and frequency of postoperative complications
Measured: Up to 30 days
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.
Measured: Through study completion, an average of 2 days
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.
Measured: Duration from postoperative chest tube placement to potential removal, an average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start20 Apr 2020
- Primary completion18 Dec 2020
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Huang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lin Huang, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletHenrik Kehlet, MD, DMSc, Study director, Copenhagen University Hospital, RigshospitaletRene H Petersen, MD, PhD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294108
- Sponsor's protocol ID
- H-20014489
- Status last verified
- Nov 2021
- First submitted
- 27 Feb 2020
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26088592Agostini 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.
PubMed 29673386Kehlet H. ERAS Implementation-Time To Move Forward. Ann Surg. 2018 Jun;267(6):998-999. doi: 10.1097/SLA.0000000000002720. No abstract available.
PubMed 29462010Das-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.
PubMed 19324571Holbek 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.
PubMed 26514281Batchelor 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.
PubMed 30304509Husted 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.
PubMed 22066560Munk-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.
PubMed 31309661Wildgaard 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.
PubMed 22219442Torre 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.
PubMed 25651787Marjanski 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.
PubMed 25721817
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Are Patients Still in Hospital After Video-Assisted Thoracoscopic Surgery Lobectomy?
- ClinicalTrials.gov ID
- NCT04294108
- Acronym / sponsor ID
- H-20014489
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 3 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent VATS lobectomy | – | Other: Prolong in-hospital stayAll consecutive patients scheduled for video-assisted thoracoscopic surgery lobectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent VATS lobectomy and writing informed consent.
Key inclusion criteria (3 listed)
- Patients referred to elective VATS lobectomy
- Speaks and understands Danish
- Informed consent obtained
Key exclusion criteria (1 listed)
- •Age < 18 years
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 |
|---|---|---|
| Prolong in-hospital stayPatients have a longer length of hospital stay than the common recommendation. | Other | Patients underwent VATS lobectomy |
Primary outcome
Length of postoperative hospital stay
Time frame: Through study completion, an average of 2 days
3 secondary outcomes
Number and frequency of postoperative complications
Time frame: Up to 30 days
Numeric rating scale for postoperative pain in hospitalization
Time frame: Through study completion, an average of 2 days
Drainage duration
Time frame: Duration from postoperative chest tube placement to potential removal, an average of 2 days
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 3 Nov 2021.
- Background: PubMed 26088592Laursen 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.
- Background: PubMed 29673386Agostini 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.
- Background: PubMed 29462010Kehlet H. ERAS Implementation-Time To Move Forward. Ann Surg. 2018 Jun;267(6):998-999. doi: 10.1097/SLA.0000000000002720. No abstract available.
- Background: PubMed 19324571Das-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.
- Background: PubMed 26514281Holbek 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.
- Background: PubMed 30304509Batchelor 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.
- Background: PubMed 22066560Husted 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.
- Background: PubMed 31309661Munk-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.
- Background: PubMed 22219442Wildgaard 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.
- Background: PubMed 25651787Torre 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.
- Background: PubMed 25721817Marjanski 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.
- Individual participant dataSharing planned: No
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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.
Lin Huang, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Henrik Kehlet, MD, DMSc study director
Copenhagen University Hospital, Rigshospitalet
Rene H Petersen, MD, PhD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Pain, Postoperative, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 1 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Length of postoperative hospital stay (time frame: Through study completion, an average of 2 days). 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 NCT04294108, which also lists 11 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 3 Nov 2021.