- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118593
Why in Hospital After Wedge Resection
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Lin Huang
- Phone Number: +4531478812
- Email: lin.huang@regionh.dk
Study Contact Backup
- Name: René H Petersen
- Phone Number: +4526494949
- Email: Rene.Horsleben.Petersen@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who underwent video-assisted thoracoscopic surgery wedge resection
Exclusion Criteria:
- < 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: Up to the day of discharge
|
Number of overnight stay
|
Up to the day of discharge
|
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
|
Up to the day of discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of chest drain
Time Frame: Up to the day of chest drain removed
|
Days of chest drain placed
|
Up to the day of chest drain removed
|
Postoperative complications
Time Frame: Up to postoperative day 30
|
Diagonosis is following ICD-10
|
Up to postoperative day 30
|
30-day readmissions
Time Frame: Up to postoperative day 30
|
Admission to hospital again within 30 days after surgery
|
Up to postoperative day 30
|
Postoperative pain scale
Time Frame: At the day of surgery
|
The pain scale (from 0 to 10) will be evaluated by patients.
|
At the day of surgery
|
Postoperative activity
Time Frame: At the day of surgery
|
Patients report whether they can stand up, walk within 6 meters, or walk over 6 meters, up to 3 and 6 hours after surgery
|
At the day of surgery
|
Opioid usage
Time Frame: At the day of surgery and at the day of discharge
|
It is classified as opioid used and no opioid used
|
At the day of surgery and at the day of discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: René H Petersen, Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P-2022-238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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