Lung Cancer, Surgery
Conditions
Keywords
Same Day Discharge, Video-Assisted Thoracoscopic Surgery (VATS), Minimally Invasive Surgery, Enhanced Recovery Pathway
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.
Interventions
PROCEDURESame 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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of eligible participants consented | From trial start until last patient consented, up to 12 months. | — |
| 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. |
| 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. |
| 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. |
Countries
Canada
Contacts
Primary ContactJonathan Spicer, MD, PhD
Outcome results
None listed