NCT05583916UnknownNot Applicable
Phase I Safety and Feasibility Pilot Study of Same-Day Discharge After Video-Assisted Thoracoscopic Surgery (VATS) Anatomical Lung or Wedge Resection (VALUE Trial)
McGill University Health Centre/Research Institute of the McGill University Health Centre2 sites in 1 country20 target enrollmentStarted: September 7, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Readmission Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Readmission Rate
Time Frame: 30 days post surgery
Rate of presentation to the emergency room after surgery
Time Frame: 30 days post surgery
Adverse Event Rate
Time Frame: 30 days post surgery
Same Day Discharge Rate
Time Frame: Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.
Secondary Outcomes
- Percent of eligible participants consented(From trial start until last patient consented, up to 12 months.)
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(30 days post surgery)
- Edmonton Symptom Assessment Scale (ESAS)(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(From trial start until last patient consented, up to 12 months.)
- Pathway adherence rate(From moment of consent until 1 day post surgery.)
Investigators
Jonathan Spicer
Assistant Professor of Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sites (2)
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