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Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis
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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259226/ https://www.ncbi.nlm.nih.gov/pubmed/34225743 http://dx.doi.org/10.1186/s13019-021-01567-y |
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author | Mendogni, Paolo Tosi, Davide Marulli, Giuseppe Comacchio, Giovanni Maria Pieropan, Sara Rossi, Veronica Brascia, Debora Andriolo, Luigi Gaetano Imbriglio, Giovanna Bonitta, Gianluca Lopez, Camillo Rea, Federico Nosotti, Mario |
author_facet | Mendogni, Paolo Tosi, Davide Marulli, Giuseppe Comacchio, Giovanni Maria Pieropan, Sara Rossi, Veronica Brascia, Debora Andriolo, Luigi Gaetano Imbriglio, Giovanna Bonitta, Gianluca Lopez, Camillo Rea, Federico Nosotti, Mario |
author_sort | Mendogni, Paolo |
collection | PubMed |
description | 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 < 0.05 was considered significant. RESULTS: From April 2017 to November 2018, out of 317 patients enrolled by 3 centers, 231 fulfilled inclusion criteria and were randomized. Twenty-two of them dropped out after randomization. Finally, 209 patients were analyzed: among them 94 used the digital device and 115 the traditional one. The overall postoperative complications were 35 (16.8%) including prolonged air leak (1.9%). Mean chest tube duration was 3.6 days (SD = 1.8), with no differences between two groups (p = 0.203). The overall difference between hospital stay and chest tube duration was 1.4 days (SD = 1.4). Air leak at first postoperative day detected by digital and traditional devices predicted increasing in tube duration of 1.6 day (CI 95% 0.8–2.5, p < 0.001) and 2.0 days (CI 95% 1.0–3.1, p < 0.001), respectively. CONCLUSIONS: This interim analysis supported the authors’ will to continue with the enrollment and to analyze data once the estimated sample size will be reached. TRIAL REGISTRATION: Trial registration number NCT03536130, Registered 24 May 2018 - Retrospectively registered. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13019-021-01567-y. |
format | Online Article Text |
id | pubmed-8259226 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-82592262021-07-06 Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis Mendogni, Paolo Tosi, Davide Marulli, Giuseppe Comacchio, Giovanni Maria Pieropan, Sara Rossi, Veronica Brascia, Debora Andriolo, Luigi Gaetano Imbriglio, Giovanna Bonitta, Gianluca Lopez, Camillo Rea, Federico Nosotti, Mario J Cardiothorac Surg Research Article 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 < 0.05 was considered significant. RESULTS: From April 2017 to November 2018, out of 317 patients enrolled by 3 centers, 231 fulfilled inclusion criteria and were randomized. Twenty-two of them dropped out after randomization. Finally, 209 patients were analyzed: among them 94 used the digital device and 115 the traditional one. The overall postoperative complications were 35 (16.8%) including prolonged air leak (1.9%). Mean chest tube duration was 3.6 days (SD = 1.8), with no differences between two groups (p = 0.203). The overall difference between hospital stay and chest tube duration was 1.4 days (SD = 1.4). Air leak at first postoperative day detected by digital and traditional devices predicted increasing in tube duration of 1.6 day (CI 95% 0.8–2.5, p < 0.001) and 2.0 days (CI 95% 1.0–3.1, p < 0.001), respectively. CONCLUSIONS: This interim analysis supported the authors’ will to continue with the enrollment and to analyze data once the estimated sample size will be reached. TRIAL REGISTRATION: Trial registration number NCT03536130, Registered 24 May 2018 - Retrospectively registered. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13019-021-01567-y. BioMed Central 2021-07-05 /pmc/articles/PMC8259226/ /pubmed/34225743 http://dx.doi.org/10.1186/s13019-021-01567-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Mendogni, Paolo Tosi, Davide Marulli, Giuseppe Comacchio, Giovanni Maria Pieropan, Sara Rossi, Veronica Brascia, Debora Andriolo, Luigi Gaetano Imbriglio, Giovanna Bonitta, Gianluca Lopez, Camillo Rea, Federico Nosotti, Mario Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis |
title | Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis |
title_full | Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis |
title_fullStr | Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis |
title_full_unstemmed | Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis |
title_short | Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis |
title_sort | multicenter randomized controlled trial comparing digital and traditional chest drain in a vats pulmonary lobectomy cohort: interim analysis |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259226/ https://www.ncbi.nlm.nih.gov/pubmed/34225743 http://dx.doi.org/10.1186/s13019-021-01567-y |
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