SurgeryNCT05067738
Same Day Discharge for Wedge Resection
A study testing same day discharge in people with Surgery and Minor, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Minor, Lung Cancer
- What is being tested?
- same day discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years of age and older who are scheduled to undergo an elective minimally invasive wedge resection of their lung.
Who cannot join
- Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) <50% predicted.
- Patient receives an intraoperative pleurodesis.
- Conversion to open thoracotomy or mini thoracotomy intraoperatively.
- Active pregnancy.
- Thoracic Revised Cardiac Risk Index Score (ThRCRI)8 >2.
- Underlying cognitive disorder resulting in inability to complete activities of daily living.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development of a Novel Same Day Discharge Program After Pulmonary Resection: A Safety and Feasibility Pilot Study
Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection
Read the detailed description
Determination of the feasibility of implementing a same day discharge program after minor pulmonary surgery. This will be determined by evaluating the percentage of participants who have chest tubes removed successfully, as well as evaluating the percentage of participants who would be classified as discharged on the day of surgery. The investigators will also be evaluating morbidity associated with this protocol by capturing rates of pleural reintervention.
- Conditions
- Surgery, Minor, Lung Cancer
- Being tested
- same day discharge
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
same day dischargeOther
same day discharge
| Study group | Role | What they receive |
|---|---|---|
| Discharge | Other | Phase 1-Patients will continue to be admitted after their surgery as is the current practice. Phase 2-Patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria. Receives: Other: same day discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful same day discharge
These patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Feb 2022
- Primary completion15 Jan 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 2 phases
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Nayak, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Rahul Nayak, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067738
- Sponsor's protocol ID
- v1.0 7 July 2021
- Status last verified
- May 2024
- First submitted
- 24 Sep 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahai D, Chaulk RC, Malthaner R, Qiabi M, Fortin D, Inculet R, Nayak R. A Novel Same Day Discharge Program After Pulmonary Wedge Resection: A Prospective Clinical Trial. CHEST Pulm. 2025 Feb 24;3(2):100148. doi: 10.1016/j.chpulm.2025.100148. eCollection 2025 Jun.
PubMed 42548370
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Novel Same Day Discharge Program After Pulmonary Resection: A Safety and Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT05067738
- Acronym / sponsor ID
- v1.0 7 July 2021
- Conditions
- Surgery, Minor, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection
Detailed description
Determination of the feasibility of implementing a same day discharge program after minor pulmonary surgery. This will be determined by evaluating the percentage of participants who have chest tubes removed successfully, as well as evaluating the percentage of participants who would be classified as discharged on the day of surgery. The investigators will also be evaluating morbidity associated with this protocol by capturing rates of pleural reintervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 phases
| Arm | Type | Receives |
|---|---|---|
| Discharge | Other | Other: same day dischargePhase 1-Patients will continue to be admitted after their surgery as is the current practice. Phase 2-Patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years of age and older who are scheduled to undergo an elective minimally invasive wedge resection of their lung.
Key exclusion criteria (6 listed)
- Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) <50% predicted.
- Patient receives an intraoperative pleurodesis.
- Conversion to open thoracotomy or mini thoracotomy intraoperatively.
- Active pregnancy.
- Thoracic Revised Cardiac Risk Index Score (ThRCRI)8 >2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| same day dischargesame day discharge | Other | Discharge |
Primary outcome
Rate of successful same day discharge
Time frame: 2 years
These patients will have their chest tube removed once they meet chest tube removal criteria and will be discharged home once they meet discharge criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 42548370Sahai D, Chaulk RC, Malthaner R, Qiabi M, Fortin D, Inculet R, Nayak R. A Novel Same Day Discharge Program After Pulmonary Wedge Resection: A Prospective Clinical Trial. CHEST Pulm. 2025 Feb 24;3(2):100148. doi: 10.1016/j.chpulm.2025.100148. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Nayak principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing same day discharge in people with Surgery and Minor, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful same day discharge (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.