This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.
Unità di Chirurgia Toracica Oncologica
Candiolo, Torino, Italy
RECRUITINGOspedale centrale di Bolzano, Chirurgia Toracica e Vascolare
Bolzano, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero-Universitaria Careggi
Florence, Italy
NOT_YET_RECRUITINGFondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
NOT_YET_RECRUITINGIrccs Ismett
Palermo, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera-Universitaria Pisana
Pisa, Italy
NOT_YET_RECRUITINGDuration of pleural drainage
Time from surgery to chest tube removal, measured in hours.
Time frame: From surgery to chest tube removal, assessed up to 30 days after surgery
Postoperative hospital length of stay
Time from surgery to hospital discharge, measured in days.
Time frame: From surgery to hospital discharge, assessed up to 30 days after surgery
Incidence and volume of postoperative air leaks
Proportion of patients with at least one documented postoperative air leak and mean daily and total postoperative air leak volume, as recorded by the digital drainage system.
Time frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Incidence of residual pleural space
Proportion of patients with residual pleural space detected on chest imaging during postoperative hospitalization or at follow-up assessment.
Time frame: During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge
Postoperative safety outcomes
Incidence of postoperative adverse events and complications, including thoracentesis, new chest drainage, hospital readmission, and re-intervention.
Time frame: During postoperative hospitalization and up to 30 days after surgery
Duration of postoperative air leak
Time from surgery to resolution of postoperative air leak, measured in hours.
Time frame: From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery
Duration of surgical procedure
Total duration of the surgical procedure, measured in minutes.
Time frame: During the surgical procedure
Mean daily and total postoperative air leak volume
Mean daily postoperative air leak volume and cumulative total postoperative air leak volume, measured in liters using the digital drainage system.
Time frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
Air leak indices corrected for length of dissected pulmonary parenchyma
Quantitative postoperative air leak measures adjusted for the length of dissected pulmonary parenchyma to standardize comparisons between patients.
Time frame: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery
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