NCT05583916

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 4, 2022

Last Update Submit

October 13, 2022

Conditions

Lung CancerSurgery

Keywords

Same Day DischargeVideo-Assisted Thoracoscopic Surgery (VATS)Minimally Invasive SurgeryEnhanced Recovery Pathway

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (6)

  • Edmonton Symptom Assessment Scale (ESAS)

    30 days post surgery

  • Functional Assessment of Cancer Therapy - Lung (FACT-L)

    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

    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.

  • +1 more secondary outcomes

Study Arms (1)

Lung Cancer Patients

OTHER

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

Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) LungPROCEDURE

All patients will be scheduled to surgery at the start of the day and will be discharged within the same day as the procedure.

Lung Cancer Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Jonathan Spicer, MD, PhD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Spicer, MD, PhD

CONTACT

514-934-1934jonathan.spicer@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 18, 2022

Study Start

September 7, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

CA(1)