1. Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis
- Author
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Paolo Mendogni, Davide Tosi, Giuseppe Marulli, Giovanni Maria Comacchio, Sara Pieropan, Veronica Rossi, Debora Brascia, Luigi Gaetano Andriolo, Giovanna Imbriglio, Gianluca Bonitta, Camillo Lopez, Federico Rea, and Mario Nosotti
- Subjects
Digital chest drainage ,Water-seal chest drainage ,Video-assisted thoracic surgery (VATS) ,Air leakage ,Postoperative complications ,Surgery ,RD1-811 ,Anesthesiology ,RD78.3-87.3 - Abstract
Abstract Background The usefulness of digital chest drain is still debated. We are carrying out a study to determine if the use of a digital system compared with a traditional system reduces the duration of chest drainage. To evaluate safety, benefit, or futility of this trial we planned the current interim analysis. Methods An interim analysis on preliminary data from ongoing investigator-initiated, multicenter, interventional, prospective randomized trial. Original protocol number: (NCT03536130). The interim main endpoint was overall complications; secondary endpoints were the concordance between the two primary endpoints of the RCT (chest tube duration and length of hospital stay). We planned the interim analysis when half of the patients have been randomised and completed the study. Data were described using mean and standard deviation or absolute frequencies and percentage. T-test for unpaired samples, Chi-square test, Poisson regression and absolute standardized mean difference (ASMD) were used. P-value
- Published
- 2021
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