Clinical trial: NCT05583916
Section: Alternatives
Subsections: Other Possible Treatments

You do not have to take part in this study to receive medical care for your condition. We encourage you to discuss with the study doctor all available options.
Clinical trial: NCT05583916
Section: Confidentiality
Subsections: Confidentiality

During your participation in this study, the study doctor and their team will collect and record information about you in a study file. They will only collect information required to meet the scientific goals of the study. The study file may include information from your medical chart, including your identity, concerning your past and present state of health, your lifestyle, and details about your cancer. Your research file could also contain other information, such as your name, sex, date of birth and ethnic origin. All the information collected during the research project will remain strictly confidential to the extent provided by law. You will only be identified by a code number. The key to the code linking your name to your study file will be kept by the study doctor.  
To ensure your safety, a copy of this information and consent form, and information related to your surgery such as operative and pathological data will be placed in your medical chart. As a result, any person or company to whom you give access to your medical chart will have access to this information. The study data will be stored for 7 years by the study doctor. The data may be published or shared during scientific meetings; however, it will not be possible to identify you. For auditing purposes, the research study files, which could include documents that may identify you, may be examined by a person mandated by the institution, or the Research Ethics Board. All these individuals and organizations adhere to policies on confidentiality. You have the right to consult your study file in order to verify the information gathered, and to have it corrected if necessary. However, in order to protect the scientific integrity of the research project, accessing certain information before the project is ended may require that you be withdrawn from the study.
Clinical trial: NCT05583916
Section: Duration of Study Involvement
Subsections: 1. Duration And Number Of Visits

Your participation in this research project will last between 2-3 months. This includes clinical visits (1 pre-operative visit, 1 surgical and post-surgical in-hospital visit, and 1 follow-up visit) during which research procedures will also occur, and will include additional research visits (3 phone follow-ups, and 1 in-person follow-up visit).
Clinical trial: NCT05583916
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Associated With The Research Study|Risks Associated With The Study Intervention|Risks Related To The Questionnaires|Risks Related To The Chest Tube|Other Risks|Should You Suffer Any Harm

The study intervention, the ERP for same-day discharge, is experimental and therefore we may not know all the discomforts, side effects and other possible risks associated with it.

These consist of anything resulting from the absence of immediate access to nurses and/or doctors as would be provided in a hospital, given that the standard discharge target for people undergoing the same surgery as you is 2 days. The risk of an early discharge would be that the same surgical complications as with any other VATS surgery. If they were to go unrecognized, it could lead to a higher severity of complication and require a re-visit with the treating doctor. Possible surgical complications can include:
- unrecognized bleeding - retaining urine longer than usual (urinary retention) - heart rhythm changes (arrhythmias) - air between the lung and the chest wall (pneumothorax).  
Your safety is the number one priority during this study. The study team does not expect any issues resulting from an early discharge home. Therefore, if you notice any issues, whatever they may be, during this research study, you must tell the study doctor immediately, regardless of whether you think these issues are related to the study intervention or not. Even once your participation in the study has ended, do not hesitate to contact the study doctor if you experience any problems that may be linked to the study intervention.

You may find upsetting or distressing to answer some questions. You can refuse to answer those questions and/or choose to stop participating in the study altogether at any time. You do not have to give any reason for refusing to answer a question or for stopping to participate. If you feel uncomfortable at any time, do not hesitate to tell the researcher(s). Our clinical nurse will evaluate your mental, physical, and emotional state to ensure a safe and comfortable questionnaire environment.

Normally, the chest tube is removed on the second day after surgery before discharge, or at a followup visit between 5 to 7 days after surgery if the patient goes home with it. To facilitate a same-day discharge, you will be going home with your chest tube. There are potential risks of taking care of your chest tube at home such as tube fall-out, difficult wound care or wound infection. In addition, you may find inconvenient to return to our clinic on the second day after surgery (and maybe on the fifth day after surgery, if necessary) to get your tube removed.

A possible risk associated with this study is a breach of confidentiality or use of your personal information by a third party. To limit this risk, we will take the steps to protect your confidentiality described in the Confidentiality section, below. The study doctor and members of his or her team will answer any questions that you may have regarding the risks, discomforts and side effects associated with this study. Also, at each visit, the study doctor and members of his or her team will ask you questions about any side effect you may have experienced.

Should you suffer harm of any kind following administration of any procedure related to the research study, you will receive the appropriate care and services required by your state of health. By agreeing to participate in this research project, you are not waiving any of your legal rights nor discharging the study doctor, the sponsor or the institution, of their civil and professional responsibilities.
Clinical trial: NCT05583916
Section: Procedures
Subsections: Description Of The Research Procedures|3. Tests And Procedures

This research study will take place at the McGill University Health Centre's academic Upper Gastrointestinal and Thoracic Surgery division located at the Montreal General Hospital (MGH).

During your participation in this research study, the study doctor or a member of the research team will conduct the following tests and procedures:  
| DESCRIPTION OF RESEARCH PROCEDURES   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Procedure                            | Description                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| Review of your medical chart         | The research team will review your medical chart to collect data  necessary for the research, such as your age, your sex, your past  medical and surgery history, your lung function test results, details  about your type of cancer, and details about your surgery including any  complication.                                                                                                                                                                    |
| Enhanced recovery pathway            | This includes counselling before surgery, nutrition optimization, pain                                                                                                                                                                                                                                                                                                                                                                                                |
| (ERP)                                | control through multiple approaches, and early ambulation (moving as  soon as possible after the surgery).  The anesthesia plan put in place in this research was created by the  Department of Anesthesiology as a consensus, and uses different  elements already done as part of standard of care, but were specifically  selected together for an optimized ERP for same-day discharge. These optimized measures aim to help early discharge home after  surgery. |
| Quality of life and symptom          | You will be asked to answer 2 short questionnaires, the Functional                                                                                                                                                                                                                                                                                                                                                                                                    |
| questionnaires                       | Assessment of Cancer Therapy - Lung (FACT-L) and the Edmonton  Symptom Assessment System (ESAS), which will assess your quality of  life and symptoms. You will be asked to complete these questionnaires, which will take                                                                                                                                                                                                                                            |
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DESCRIPTION OF RESEARCH PROCEDURES  
Procedure **Description**  
approximately 5 minutes, at the time of consenting to the study, on the day of your surgery, after chest tube removal and on day 30 after your surgery.  
Chest tube insertion As part of your surgery, a chest tube drain will be inserted in one of the  
incisions to allow for air between the lung and the chest wall to be suctioned and permit the lung to re-expand. This is performed for anyone receiving the same surgery as yours.  
| DESCRIPTION OF RESEARCH PROCEDURES                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Procedure                                                                                                                                                 | Description                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| approximately 5 minutes, at the time of consenting to the study, on the  day of your surgery, after chest tube removal and on day 30 after your  surgery. |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
| Chest tube insertion                                                                                                                                      | As part of your surgery, a chest tube drain will be inserted in one of the  incisions to allow for air between the lung and the chest wall to be  suctioned and permit the lung to re-expand. This is performed for  anyone receiving the same surgery as yours. However, as part of the research, you will also be discharged with this  tube in place and the device attached to it. The chest tube drain is  connected to a small portable drainage system reservoir called the Mini  Atrium 500 which allows for air and fluid suction and emptying.  The chest tube should always be secured to your skin with a wide piece  of tape to prevent accidental movement of the tube. Avoid sudden  movements that can result in dislodgement of the tube and prevent  any pulling on the tube. The chest tube site needs to remain clean; the  nursing staff will instruct you on the proper way to ensure cleanliness  of the site as well as how to take care of the tube. Ensure that the  connections between the portable drainage system and the tube are  well secured and do not come apart. If the tube accidentally pulls out,  notify the clinical team right away. |
| Follow-up visits                                                                                                                                          | Your surgeon and their team will see you call you daily until chest tube  drain removal or post-operative day 5. You will be seen in follow-up on  post-operative day 2, and on day 5 if your chest tube was not removed  on day 2.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |  
The schedule of procedures for each visit is listed below:  
| SCHEDULE OF STUDY PROCEDURES   |                                     |                                         |                                        |                                          |                                        |    |
|--------------------------------|-------------------------------------|-----------------------------------------|----------------------------------------|------------------------------------------|----------------------------------------|----|
| Procedure                      | Prior to  surgery (Day of  consent) | Visit 7 (After  your  surgery,  Day 30) |                                        |                                          |                                        |    |
| Quality of life                | X                                   | X                                       | +                                      | +                                        | X                                      |    |
| questionnaires                 | Visit 1                             | Visit 2                                 |                                        |                                          |                                        |    |
| (Surgery)                      | (After your  surgery)               | Visit 3 (After  your  surgery,  Day 1)  | Visit 4 (After  your  surgery,  Day 2) | Visit 5 (After  your  surgery,  Day 3-4) | Visit 6 (After  your  surgery,  Day 5) |    |
| Follow-up visits               | X                                   | *                                       | X                                      | *                                        | #                                      | *  |
| Chest tube                     | +                                   | +                                       |                                        |                                          |                                        |    |
| removal Legend:                |                                     |                                         |                                        |                                          |                                        |    |  
*: These visits are phone follow-ups. \#: This visit may occur if needed.
Clinical trial: NCT05583916
Section: Purpose of Research
Subsections: Purpose Of The Research Study|Benefits Associated With The Research Study

The purpose of this study is to evaluate the safety and feasibility of same-day discharge in selected participants undergoing minimally-invasive lung surgery and who receive an ERP. Moreover, we aim to assess the impact on complications and recovery using this specific ERP for same-day discharge. For this research study, we will recruit 20 participants, men and women, aged 18 and above.

You may or may not personally benefit from your participation in this research project. However, we hope that the study results will contribute to the advancement of scientific knowledge in the study field and help us find better treatments for patients.
Clinical trial: NCT05583916
Section: Voluntary Participation
Subsections: 2. Overview Of Study Participation|Voluntary Participation And The Right To Withdraw

If you agree to participate in this research study, the surgery will be done in the same way as if you decide to not participate in this study. If you agree to participate in this research study, you will be asked to follow the ERP that includes counselling before surgery, nutrition optimization, pain control through multiple approaches, and early ambulation (moving as soon as possible after the surgery), and to complete two questionnaires at different moment in the study (described below). If you meet certain criteria, you will leave the hospital on the same day as the day of surgery. Usually, people who have the same surgery as yours stay in the hospital for 2 days. Leaving the hospital the same day is done only for the research. You are advised to have an experienced caregiver capable of responding to your needs upon discharge (leaving the hospital). After the surgery, a tube will be inserted into your chest and connected to a small portable draining device, which is done for anyone receiving the same surgery as yours. However, as part of the research, you will also be discharged with this tube in place and the device. The tube will be removed as soon as no air or large amounts of bloody fluid are being drained anymore. This can be as early as on the second postoperative day.

Your participation in this research project is voluntary. Therefore, you may refuse to participate. You may also withdraw from the project at any time, without giving any reason, by informing the study doctor or a member of the research team. Your decision not to participate in the study, or to withdraw from it, will have no impact on the quality of care and services to which you are otherwise entitled, or on your relationship with the study doctor or clinical team. The study doctor, or the Research Ethics Board may put an end to your participation without your consent. This may happen if new findings or information indicate that participation is no longer in your interest, if you do not follow study instructions, or if there are administrative reasons to terminate the project. If you withdraw or are withdrawn from the study, the information already collected for the study will be stored, analyzed and used to ensure the integrity of the study. Any new findings that could influence your decision to stay in the research project will be shared with you as soon as possible.