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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Surgery
• Intervention / Treatment: Procedure: Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Spicer, MD, PhD; Phone Number: 43050 514-934-1934; Email: jonathan.spicer@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre
      • Contact: Jonathan Spicer, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lung Cancer Patients; Patients with stage I or II primary lung cancer or pulmonary metastasis scheduled to undergo surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Event Rate	30 days post surgery
Same Day Discharge Rate	Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.
Readmission Rate	30 days post surgery
Rate of presentation to the emergency room after surgery	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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.
Percent of eligible participants consented		From trial start until last patient consented, up to 12 months.
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.

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Jonathan Spicer, MD, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Minimally Invasive Surgery; Same Day Discharge; Video-Assisted Thoracoscopic Surgery (VATS); Enhanced Recovery Pathway
• Other Study ID Numbers: 2021-7318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No