Why in Hospital After Wedge Resection

Enhanced Recovery After Surgery Clinical Trial

Official title:

Why in Hospital After ERAS VATS Wedge Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06118593
• Other study ID #: P-2022-238
• Status: Completed
• Start date: November 15, 2022
• Est. completion date: January 28, 2024

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 28, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Thoracic Surgery, Video-Assisted

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Number of overnight stay	Up to the day of discharge
Primary	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	Postoperative pain scale	The pain scale (from 0 to 10) will be evaluated by patients.	At the day of surgery
Secondary	Duration of chest drain	Days of chest drain placed	Up to the day of chest drain removed
Secondary	Postoperative complications	Diagonosis is following ICD-10	Up to postoperative day 30
Secondary	30-day readmissions	Admission to hospital again within 30 days after surgery	Up to postoperative day 30
Secondary	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	At the day of surgery
Secondary	Opioid usage	It is classified as opioid used and no opioid used	At the day of surgery and at the day of discharge