Overview
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization.
The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.
Description
Lobectomy is the standard surgical treatment for many patients with early-stage NSCLC, but postoperative air leak remains a frequent complication associated with prolonged chest tube duration, longer hospitalization, and increased healthcare costs. Preliminary non-randomized evidence suggests that Progel Platinum may improve intraoperative sealing of fissure lines and reduce postoperative air leaks. E-SEAL is a prospective, randomized, controlled, multicenter study in 8 thoracic surgery centers. Eligible adult patients undergoing minimally invasive VATS upper or lower lobectomy for NSCLC are randomized 1:1 to stapling alone or stapling plus Progel Platinum. The primary endpoint is pleural drainage duration in hours. Secondary endpoints include postoperative length of stay, hospitalization costs, postoperative air leak incidence and volume, residual pleural space, complications, re-interventions, and follow-up outcomes up to 60 days after surgery/discharge.
Eligibility
Inclusion Criteria:
- Age ≥18 years
- Written informed consent
- Planned VATS upper or lower lobectomy for NSCLC
- Minimally invasive thoracoscopic approach
- Middle lobectomy excluded
Exclusion Criteria:
- Induction radiochemotherapy or chemo-immunotherapy
- Severe COPD: GOLD 3 or higher
- Sleeve resection or extended resection involving other lobes/chest wall/pericardium, etc.
- Albumin intolerance/allergy
- Renal insufficiency
- Redo surgery
- Use of sealants/adhesives other than the study approach
- Expected extensive pleural adhesions
