Thoracic Surgery, Video-AssistedNCT06118593
Why in Hospital After Wedge Resection
An observational study of Thoracic Surgery, Video-Assisted and Enhanced Recovery After Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
In the realm of lung surgery, video-assisted thoracoscopic surgery (VATS) offers distinct advantages, including shorter hospital stays, reduced pain, improved quality of life, and increased postoperative mobility when compared to thoracotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Video-Assisted, Enhanced Recovery After Surgery
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2022to 28 Jan 2024
- 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 who underwent video-assisted thoracoscopic surgery wedge resection.
Who may be able to join
- Patients who underwent video-assisted thoracoscopic surgery wedge resection
Who cannot join
- < 18 year old
- Unable to understand Danish
- No residence in the Eastern Denmark
- Transfer to anatomical resection or cancel surgery
- Reject to join or withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Why in Hospital After ERAS VATS Wedge Resection
In the realm of lung surgery, video-assisted thoracoscopic surgery (VATS) offers distinct advantages, including shorter hospital stays, reduced pain, improved quality of life, and increased postoperative mobility when compared to thoracotomy. Additionally, the enhanced recovery after surgery (ERAS) protocol in lung surgery, characterized by a comprehensive, multidisciplinary approach, have streamlined postoperative recovery, resulting in early discharge and diminished postoperative complications. However, drawing from our extensive experience with fully implemented ERAS VATS for patients undergoing pulmonary lobectomy, we observed that approximately 45% of patients did not experience early discharge.
Based on existing evidence, the length of stay (LOS) following wedge resection typically ranges from 3 to 6 days across various regions, including Europe, the United States, and China. However, there is a notable lack of procedure-specific data for ERAS VATS wedge resection to explore reasons of delaying discharge. This prompts us to undertake an investigation into individuals following pulmonary wedge resection under the same ERAS programs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of overnight stay
Measured: Up to the day of discharge
Reasons for staying in hospital
patient-reported outcomes for why in hospital, including pain or social factors; postoperative complications, diagnosed by clinicians
Measured: Up to the day of discharge
Secondary outcomes (6)
Postoperative pain scale
The pain scale (from 0 to 10) will be evaluated by patients.
Measured: At the day of surgery
Duration of chest drain
Days of chest drain placed
Measured: Up to the day of chest drain removed
Postoperative complications
Diagonosis is following ICD-10
Measured: Up to postoperative day 30
30-day readmissions
Admission to hospital again within 30 days after surgery
Measured: Up to postoperative day 30
Postoperative activity
Patients report whether they can stand up, walk within 6 meters, or walk over 6 meters, up to 3 and 6 hours after surgery
Measured: At the day of surgery
Opioid usage
It is classified as opioid used and no opioid used
Measured: At the day of surgery and at the day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start15 Nov 2022
- Primary completion28 Jan 2024
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Surgery, Video-AssistedStudies 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
- 150 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
- René H Petersen, Study director, Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118593
- Sponsor's protocol ID
- P-2022-238
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data is possible shared to other researchers if they contact with study director and the approvals are obtained subsequently.
Publications
Huang L, Kehlet H, Petersen RH. Why do patients stay in hospital after enhanced recovery thoracoscopic wedge resection? A prospective observational study. Eur J Cardiothorac Surg. 2024 Oct 1;66(4):ezae366. doi: 10.1093/ejcts/ezae366.
PubMed 39374548
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why in Hospital After ERAS VATS Wedge Resection
- ClinicalTrials.gov ID
- NCT06118593
- Acronym / sponsor ID
- P-2022-238
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 7 Nov 2023 (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.
In the realm of lung surgery, video-assisted thoracoscopic surgery (VATS) offers distinct advantages, including shorter hospital stays, reduced pain, improved quality of life, and increased postoperative mobility when compared to thoracotomy. Additionally, the enhanced recovery after surgery (ERAS) protocol in lung surgery, characterized by a comprehensive, multidisciplinary approach, have streamlined postoperative recovery, resulting in early discharge and diminished postoperative complications. However, drawing from our extensive experience with fully implemented ERAS VATS for patients undergoing pulmonary lobectomy, we observed that approximately 45% of patients did not experience early discharge.
Based on existing evidence, the length of stay (LOS) following wedge resection typically ranges from 3 to 6 days across various regions, including Europe, the United States, and China. However, there is a notable lack of procedure-specific data for ERAS VATS wedge resection to explore reasons of delaying discharge. This prompts us to undertake an investigation into individuals following pulmonary wedge resection under the same ERAS programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent video-assisted thoracoscopic surgery wedge resection.
Key inclusion criteria (1 listed)
- Patients who underwent video-assisted thoracoscopic surgery wedge resection
Key exclusion criteria (5 listed)
- < 18 year old
- Unable to understand Danish
- No residence in the Eastern Denmark
- Transfer to anatomical resection or cancel surgery
- Reject to join or withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: Up to the day of discharge
Number of overnight stay
Reasons for staying in hospital
Time frame: Up to the day of discharge
patient-reported outcomes for why in hospital, including pain or social factors; postoperative complications, diagnosed by clinicians
6 secondary outcomes
Postoperative pain scale
Time frame: At the day of surgery
Duration of chest drain
Time frame: Up to the day of chest drain removed
Postoperative complications
Time frame: Up to postoperative day 30
30-day readmissions
Time frame: Up to postoperative day 30
Postoperative activity
Time frame: At the day of surgery
Opioid usage
Time frame: At the day of surgery and at the day of discharge
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 6 Feb 2024.
- Derived from this study: PubMed 39374548Huang L, Kehlet H, Petersen RH. Why do patients stay in hospital after enhanced recovery thoracoscopic wedge resection? A prospective observational study. Eur J Cardiothorac Surg. 2024 Oct 1;66(4):ezae366. doi: 10.1093/ejcts/ezae366.
- Individual participant dataSharing planned: Undecided. The data is possible shared to other researchers if they contact with study director and the approvals are obtained subsequently.
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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.
René H Petersen study director
Department of Cardiothoracic Surgery, 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 Thoracic Surgery, Video-Assisted and Enhanced Recovery After Surgery, 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 1 inclusion and 5 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 6 Feb 2024. 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 stay (time frame: Up to the day of discharge). The study lists 2 primary outcomes in all. 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 NCT06118593, which also lists 1 linked publication.
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 6 Feb 2024.