Why in Hospital After Wedge Resection

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT06118593

Collaborator

(none)

150

Enrollment

Location

17.5

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Surgery, Video-Assisted Enhanced Recovery After Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Why in Hospital After ERAS VATS Wedge Resection

Actual Study Start Date :

Nov 15, 2022

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Outcome Measures

Primary Outcome Measures

Length of stay [Up to the day of discharge]
Number of overnight stay

Secondary Outcome Measures

Postoperative pain scale [Up to the day of discharge]
The pain scale (from 0 to 10) will be evaluated by patients.
Duration of chest drain [Up to the day of chest drain removed]
Days of chest drain placed
Postoperative complications [Up to postoperative day 30]
Diagonosis is following ICD-10
30-day readmissions [Up to postoperative day 30]
Admission to hospital again within 30 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Director: René H Petersen, Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lin Huang, Department of Cardiothoracic Surgery, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT06118593

Other Study ID Numbers:

P-2022-238

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 8, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 8, 2023