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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer, Surgery

Intervention / Treatment
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* Procedure: Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lung Cancer Patients<br>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<br>* All patients will be scheduled to surgery at the start of the day and will be discharged within the same day as the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Same Day Discharge, Video-Assisted Thoracoscopic Surgery (VATS), Minimally Invasive Surgery, Enhanced Recovery Pathway