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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Cancer Patients | Other | Patients with stage I or II primary lung cancer or pulmonary metastasis scheduled to undergo surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung | Procedure | All patients will be scheduled to surgery at the start of the day and will be discharged within the same day as the procedure. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Spicer, MD, PhD | Contact | 514-934-1934 | 43050 | jonathan.spicer@mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Spicer, MD, PhD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40780316 | Derived | Walsh LC, Rokah M, Seitlinger J, Gallina FT, Huynh C, Gold MS, Sengupta A, Nicholls-Wallace T, Cronin E, Dehghani M, Rayes R, Mulder D, Sirois C, Rousseau M, Ferri L, Cools-Lartigue J, Costescu F, Najmeh S, Spicer JD. VALUE Trial: Phase 1 safety and feasibility study of same-day discharge after video-assisted thoracoscopic surgery lung resection. J Thorac Cardiovasc Surg. 2026 Jan;171(1):33-39. doi: 10.1016/j.jtcvs.2025.07.040. Epub 2025 Aug 6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2022 | Oct 5, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2022 | Sep 29, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |