A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study
Background: The optimal placement of a chest drain after video-assisted minimally invasive lobectomy should facilitate the aspiration of air and drainage of fluid. Typically, a conventional 24Ch polyvinyl chloride chest drain is used for this purpose. However, there is currently no scientific litera...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | Heliyon |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844023092575 |
| _version_ | 1827577599970246656 |
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| author | Davor Stamenovic Eileen Dittmar Philipp Schiller Darko Trenchev Ioannis Karampinis Christian Galata Eric Roessner |
| author_facet | Davor Stamenovic Eileen Dittmar Philipp Schiller Darko Trenchev Ioannis Karampinis Christian Galata Eric Roessner |
| author_sort | Davor Stamenovic |
| collection | DOAJ |
| description | Background: The optimal placement of a chest drain after video-assisted minimally invasive lobectomy should facilitate the aspiration of air and drainage of fluid. Typically, a conventional 24Ch polyvinyl chloride chest drain is used for this purpose. However, there is currently no scientific literature available on the impact of drain diameter on postoperative outcomes following anatomical lung resection. Methods: This is a prospective, randomized, phase-1 trial that will include 40 patients, which will be randomly assigned into two groups. Group 1 will receive a 24 French chest drain according to current standards, while group 2 will receive a 14 French drain. Primary endpoint of the trial is the incidence of postoperative drainage-related complications, such as obstruction, dislocation, pleural effusion, and reintervention. Secondary endpoints are postoperative pain, chest drainage duration, incidence of complications, and hospital length of stay. The study aims to determine the number of subjects needed to achieve a sufficient test power of 0.8 for a non-inferiority study. Discussion: Thoracic surgery is becoming more and more minimally invasive. One of the remaining unresolved problems is postoperative pain, with the intercostal drain being one of the main contributing factors. Previous data from other studies suggest that the use of small-bore drains can reduce pain and speed up recovery without an increase in drain-related complications. However, no studies have been conducted on patients undergoing anatomic lung resections to date. The initial step in transitioning from larger to smaller drains is to establish the safety of this approach, which is the primary objective of this trial.Trial registration: The study has been registered in the German Clinical Trials Register.Registration number: DRKS00029982.URL: https://drks.de/search/de/trial/DRKS00029982. |
| first_indexed | 2024-03-08T21:29:10Z |
| format | Article |
| id | doaj.art-62c47380ff9743aab7b968a11b7958cc |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-03-08T21:29:10Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-62c47380ff9743aab7b968a11b7958cc2023-12-21T07:33:11ZengElsevierHeliyon2405-84402023-12-01912e22049A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 studyDavor Stamenovic0Eileen Dittmar1Philipp Schiller2Darko Trenchev3Ioannis Karampinis4Christian Galata5Eric Roessner6Department of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyDepartment of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyDepartment of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyDepartment of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyCorresponding author.; Department of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyDepartment of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyDepartment of Thoracic Surgery, Center for Thoracic Diseases, University Hospital Mainz, Mainz University, GermanyBackground: The optimal placement of a chest drain after video-assisted minimally invasive lobectomy should facilitate the aspiration of air and drainage of fluid. Typically, a conventional 24Ch polyvinyl chloride chest drain is used for this purpose. However, there is currently no scientific literature available on the impact of drain diameter on postoperative outcomes following anatomical lung resection. Methods: This is a prospective, randomized, phase-1 trial that will include 40 patients, which will be randomly assigned into two groups. Group 1 will receive a 24 French chest drain according to current standards, while group 2 will receive a 14 French drain. Primary endpoint of the trial is the incidence of postoperative drainage-related complications, such as obstruction, dislocation, pleural effusion, and reintervention. Secondary endpoints are postoperative pain, chest drainage duration, incidence of complications, and hospital length of stay. The study aims to determine the number of subjects needed to achieve a sufficient test power of 0.8 for a non-inferiority study. Discussion: Thoracic surgery is becoming more and more minimally invasive. One of the remaining unresolved problems is postoperative pain, with the intercostal drain being one of the main contributing factors. Previous data from other studies suggest that the use of small-bore drains can reduce pain and speed up recovery without an increase in drain-related complications. However, no studies have been conducted on patients undergoing anatomic lung resections to date. The initial step in transitioning from larger to smaller drains is to establish the safety of this approach, which is the primary objective of this trial.Trial registration: The study has been registered in the German Clinical Trials Register.Registration number: DRKS00029982.URL: https://drks.de/search/de/trial/DRKS00029982.http://www.sciencedirect.com/science/article/pii/S2405844023092575Thoracic surgeryUniportal VATSLung surgeryLobectomyChest tubeThoracic drainage |
| spellingShingle | Davor Stamenovic Eileen Dittmar Philipp Schiller Darko Trenchev Ioannis Karampinis Christian Galata Eric Roessner A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study Heliyon Thoracic surgery Uniportal VATS Lung surgery Lobectomy Chest tube Thoracic drainage |
| title | A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study |
| title_full | A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study |
| title_fullStr | A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study |
| title_full_unstemmed | A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study |
| title_short | A randomized controlled trial: Comparison of 14 and 24 French thoracic drainage after minimally invasive lobectomy – MZ 14-24 study |
| title_sort | randomized controlled trial comparison of 14 and 24 french thoracic drainage after minimally invasive lobectomy mz 14 24 study |
| topic | Thoracic surgery Uniportal VATS Lung surgery Lobectomy Chest tube Thoracic drainage |
| url | http://www.sciencedirect.com/science/article/pii/S2405844023092575 |
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