CClinicalTrials.gg
Status unknownNCT05583916VALUEUpdated Oct 18, 2022

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

An interventional study of Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung in Lung Cancer and Surgery, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-18.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer
  • Surgery

Keywords

  • Same Day Discharge
  • Video-Assisted Thoracoscopic Surgery (VATS)
  • Minimally Invasive Surgery
  • Enhanced Recovery Pathway
03

In context

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Lung Cancer Patients

    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

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.

06

What researchers measure

Primary outcomes

  1. Adverse Event Rate

    Time frame: 30 days post surgery

  2. Same Day Discharge Rate

    Time frame: Throughout the trial, from start until completion of surgery for all the patients, up to 12 months.

  3. Readmission Rate

    Time frame: 30 days post surgery

  4. Rate of presentation to the emergency room after surgery

    Time frame: 30 days post surgery

Secondary outcomes

  1. 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.

    Time frame: 30 days post surgery

  2. 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').

    Time frame: 30 days post surgery

  3. Duration of indwelling chest tube catheter

    Time frame: 30 days post surgery or until the chest tube is removed (whichever comes last, assessed until 90 days post surgery)

  4. Rate of screen failure

    Feasibility calculation of the number of patients approached to participate compared to the number of patients consented to the trial.

    Time frame: From trial start until last patient consented, up to 12 months.

  5. Percent of eligible participants consented

    Time frame: From trial start until last patient consented, up to 12 months.

  6. 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.

    Time frame: From moment of consent until 1 day post surgery.

07

Study locations

1 of 1 sites recruiting
  • McGill University Health Centre
    Montreal, Quebec H4A 3J1, Canada
    • Jonathan Spicer, MD PhD · Contact
    Recruiting
08

References and documents

Study documents

  • Study protocol · Jul 27, 2022
  • Informed consent form · Jul 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05583916
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Jonathan Spicer (Assistant Professor of Surgery, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Oct 18, 2022
Start date
Sep 7, 2022
Primary completion
Oct 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Oct 18, 2022

Study contacts

Jonathan Spicer, MD, PhD
Contact
jonathan.spicer@mcgill.ca
514-934-1934 ext. 43050
Jonathan Spicer, MD, PhD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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