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

  • STATUS
    Recruiting
  • End date
    Oct 22, 2023
  • participants needed
    20
  • sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
Updated on 22 October 2022
cancer
lung cancer
lung surgery
lung carcinoma

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.

Details
Condition Lung Cancer, Surgery
Treatment Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung
Clinical Study IdentifierNCT05583916
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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