Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery

Lung Cancer Clinical Trial

— VALUE  

Official title:

Phase I Safety and Feasibility Pilot Study of Same-Day Discharge After Video-Assisted Thoracoscopic Surgery (VATS) Anatomical Lung or Wedge Resection (VALUE Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583916
• Other study ID #: 2021-7318
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: October 2023

Study information

• Verified date: October 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Jonathan Spicer, MD, PhD
• Phone: 514-934-1934
• Email: jonathan.spicer[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an enhanced recovery pathway.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed or verbal informed consent by participant

• Male and female adults, age 18 and above

• Clinical stage I-II lung cancer (suspected, proven, unproven), or secondary pulmonary malignancy

• BMI < 35

• ECOG 0-1

• Eligible for surgery and lung cancer resection (FEV1 > 60%, DLCO > 60%)

• Elective VATS anatomic resection (segmentectomy or lobectomy), or wedge resection

• Capable caregiver for discharge home

Exclusion Criteria:

• Clinical stage III lung cancer

• Surgery requiring pneumonectomy

• Neoadjuvant therapy

• Active pregnancy or breastfeeding

• History of chronic pain syndromes

• History of chronic opioid use

• Concomitant major surgery indicated with current admission to hospital

• Anticipated intraoperative complication including conversion to thoracotomy, major bleeding requiring blood transfusion, extensive adhesiolysis, injury to mediastinal structures, airway injury, nerve injury (phrenic, recurrent)

• Need for epidural or patient-controlled intravenous analgesia

• Need for urinary catheter

Related Conditions & MeSH terms

• Lung Cancer
• Surgery

Intervention

Procedure:
• Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung
All patients will be scheduled to surgery at the start of the day and will be discharged within the same day as the procedure.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Rate		30 days post surgery
Primary	Same Day Discharge Rate		Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.
Primary	Readmission Rate		30 days post surgery
Primary	Rate of presentation to the emergency room after surgery		30 days post surgery
Secondary	Edmonton Symptom Assessment Scale (ESAS)	Rating pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath, on a scale of 1 to 10. Higher scores indicate more serious symptoms.	30 days post surgery
Secondary	Functional Assessment of Cancer Therapy - Lung (FACT-L)	Rating questions regarding physical, social/family, emotion and function well-being as well as general questions regarding medical health, on a scale of 0-4 (from 'Not at all' to 'Very much').	30 days post surgery
Secondary	Duration of indwelling chest tube catheter		30 days post surgery or until the chest tube is removed (whichever comes last, assessed until 90 days post surgery)
Secondary	Rate of screen failure	Feasibility calculation of the number of patients approached to participate compared to the number of patients consented to the trial.	From trial start until last patient consented, up to 12 months.
Secondary	Percent of eligible participants consented		From trial start until last patient consented, up to 12 months.
Secondary	Pathway adherence rate	Calculation of the number of participants who stay on the same-day discharge pathway versus number of patients who deviate from the protocol.	From moment of consent until 1 day post surgery.