VALUE: Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Edmonton Symptom Assessment Scale (ESAS) [30 days post surgery]
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.
- Functional Assessment of Cancer Therapy - Lung (FACT-L) [30 days post surgery]
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').
- 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 [From trial start until last patient consented, up to 12 months.]
Feasibility calculation of the number of patients approached to participate compared to the number of patients consented to the trial.
- Percent of eligible participants consented [From trial start until last patient consented, up to 12 months.]
- Pathway adherence rate [From moment of consent until 1 day post surgery.]
Calculation of the number of participants who stay on the same-day discharge pathway versus number of patients who deviate from the protocol.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed or verbal informed consent by participant
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Male and female adults, age 18 and above
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Clinical stage I-II lung cancer (suspected, proven, unproven), or secondary pulmonary malignancy
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BMI < 35
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ECOG 0-1
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Eligible for surgery and lung cancer resection (FEV1 > 60%, DLCO > 60%)
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Elective VATS anatomic resection (segmentectomy or lobectomy), or wedge resection
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Capable caregiver for discharge home
Exclusion Criteria:
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Clinical stage III lung cancer
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Surgery requiring pneumonectomy
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Neoadjuvant therapy
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Active pregnancy or breastfeeding
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History of chronic pain syndromes
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History of chronic opioid use
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Concomitant major surgery indicated with current admission to hospital
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Anticipated intraoperative complication including conversion to thoracotomy, major bleeding requiring blood transfusion, extensive adhesiolysis, injury to mediastinal structures, airway injury, nerve injury (phrenic, recurrent)
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Need for epidural or patient-controlled intravenous analgesia
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Need for urinary catheter
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McGill University Health Centre | Montreal | Quebec | Canada | H4A 3J1 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
More Information
Publications
None provided.- 2021-7318