NCT06118593

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

Study Start

First participant enrolled

November 15, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

November 1, 2023

Last Update Submit

February 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Length of stay

    Number of overnight stay

    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

    Up to the day of discharge

Secondary Outcomes (6)

  • Postoperative pain scale

    At the day of surgery

  • Duration of chest drain

    Up to the day of chest drain removed

  • Postoperative complications

    Up to postoperative day 30

  • 30-day readmissions

    Up to postoperative day 30

  • Postoperative activity

    At the day of surgery

  • +1 more secondary outcomes

Eligibility Criteria

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

Patients who underwent video-assisted thoracoscopic surgery wedge resection.

You may qualify if:

  • Patients who underwent video-assisted thoracoscopic surgery wedge resection

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

Study Officials

  • René H Petersen

    Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Cardiothoracic Surgery

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

November 15, 2022

Primary Completion

January 28, 2024

Study Completion

January 28, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations