Evolution in Laparoscopic Gastrectomy From a Randomized Controlled Trial Through National Clinical Practice
Annals of Surgery, vol. 279, pp. 394–401
Abstract
OBJECTIVE: To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. BACKGROUND: Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. METHODS: Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012-2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes before, during, and after the LOGICA RCT. RESULTS: Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift toward a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction in overall [adjusted odds ratio (aOR):0.62; 95% CI: 0.46-0.82], severe (aOR: 0.64; 95% CI: 0.46-0.90) and cardiac complications (aOR: 0.51; 95% CI: 0.30-0.89) after the LOGICA trial. CONCLUSIONS: The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.
Authors 19
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Sheraz Rehan Markar corresponding
University Medical Center Utrecht · University of Oxford
Affiliation as printed
Department of Upper Gastrointestinal Surgery, University Medical Center Utrecht, The Netherlands
Nuffield Department of Surgery, University of Oxford, UK
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University Medical Center Utrecht · Dutch Institute for Clinical Auditing
Affiliation as printed
Department of Upper Gastrointestinal Surgery, University Medical Center Utrecht, The Netherlands
Scientific Bureau, Dutch Institute for Clinical Auditing, Leiden, The Netherlands
Scientific Bureau, Dutch Institute for Clinical Auditing, Leiden, the Netherlands
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University Medical Center Utrecht
Affiliation as printed
Department of Upper Gastrointestinal Surgery, University Medical Center Utrecht, The Netherlands
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Affiliation as printed
Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands
Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands
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Affiliation as printed
Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands
Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands
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Affiliation as printed
Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, The Netherlands
Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, the Netherlands
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Affiliation as printed
Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, The Netherlands
Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, the Netherlands
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Affiliation as printed
Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands
Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
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Affiliation as printed
Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands
Department of Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands
Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands
Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands
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Ewout A. Kouwenhoven corresponding
Affiliation as printed
Department of Surgery, ZGT Hospitals, Almelo, The Netherlands
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Gelre Hospitals · University Medical Center Utrecht
Affiliation as printed
Department of Surgery, Gelre Hospitals, Apeldoorn, The Netherlands
Department of Upper Gastrointestinal Surgery, University Medical Center Utrecht, Netherlands
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Dutch Institute for Clinical Auditing · Meander Medisch Centrum
Affiliation as printed
Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands
Scientific Bureau, Dutch Institute for Clinical Auditing, Leiden, the Netherlands
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Amsterdam UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Cancer Treatment and Quality of Life, Cancer Center Amsterdam, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Cancer Treatment and Quality of Life, Cancer Center Amsterdam, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
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Zuyderland Medisch Centrum · Cancer Center Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Cancer Treatment and Quality of Life, Cancer Center Amsterdam, Amsterdam, The Netherlands
Department of Surgery, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands
Department of Surgery, Zuyderland Medical Center, Heerlen and Sittard-Geleen, the Netherlands
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University Medical Center Utrecht
Affiliation as printed
Department of Upper Gastrointestinal Surgery, University Medical Center Utrecht, The Netherlands
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University Medical Center Utrecht
Affiliation as printed
Department of Upper Gastrointestinal Surgery, University Medical Center Utrecht, The Netherlands
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