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

Not Applicable

Recruiting

• Conditions: Surgery; Lung Cancer
• Interventions: Procedure: Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung

• Registration Number: NCT05583916
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-07
• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Cancer Patients	Same Day Discharge - Video-Assisted Thoracoscopic Surgery (VATS) Lung	Patients with stage I or II primary lung cancer or pulmonary metastasis scheduled to undergo surgery.

Primary Outcome Measures

Name	Time	Method
Readmission Rate	30 days post surgery
Rate of presentation to the emergency room after surgery	30 days post surgery
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.

Secondary Outcome Measures

Name	Time	Method
Percent of eligible participants consented	From trial start until last patient consented, up to 12 months.
Functional Assessment of Cancer Therapy - Lung (FACT-L)	30 days post surgery	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').
Edmonton Symptom Assessment Scale (ESAS)	30 days post surgery	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.
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.	Feasibility calculation of the number of patients approached to participate compared to the number of patients consented to the trial.
Pathway adherence rate	From moment of consent until 1 day post surgery.	Calculation of the number of participants who stay on the same-day discharge pathway versus number of patients who deviate from the protocol.

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada