Clinical trial NCT05583916: Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Surgery
Keywords: Same Day Discharge
Video-Assisted Thoracoscopic Surgery (VATS)
Minimally Invasive Surgery
Enhanced Recovery Pathway
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Event Rate
timeFrame: 30 days post surgery
measure: Same Day Discharge Rate
timeFrame: Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.
measure: Readmission Rate
timeFrame: 30 days post surgery
measure: Rate of presentation to the emergency room after surgery
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 30 days post surgery
measure: Functional Assessment of Cancer Therapy - Lung (FACT-L)
timeFrame: 30 days post surgery
measure: Duration of indwelling chest tube catheter
timeFrame: 30 days post surgery or until the chest tube is removed (whichever comes last, assessed until 90 days post surgery)
measure: Rate of screen failure
timeFrame: From trial start until last patient consented, up to 12 months.
measure: Percent of eligible participants consented
timeFrame: From trial start until last patient consented, up to 12 months.
measure: Pathway adherence rate
timeFrame: From moment of consent until 1 day post surgery.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Jonathan Spicer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: