Evolution in Laparoscopic Gastrectomy From a Randomized Controlled Trial Through National Clinical Practice.

Area of Science:

• Surgical oncology and gastrointestinal surgery.
• Clinical trial methodology and health services research.
• Minimally invasive surgical techniques.

Background:

• Dissemination of complex interventions post-randomized controlled trials (RCTs) is understudied.
• The LOGICA RCT compared laparoscopic versus open gastrectomy across 10 Dutch centers.
• Gastrectomy is a critical procedure for upper gastrointestinal cancers.

Purpose of the Study:

• To evaluate the impact of the LOGICA RCT on laparoscopic gastrectomy practice and outcomes in the Netherlands.
• To assess the national adoption and safety of minimally invasive gastrectomy techniques.
• To analyze clinical outcomes before, during, and after the LOGICA RCT.

Main Methods:

• Utilized data from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) and the LOGICA RCT (2015-2018).
• Included all gastrectomies performed in the Netherlands between 2012 and 2021.
• Employed multilevel multivariable logistic regression to compare laparoscopic versus open gastrectomy outcomes.

Main Results:

• Laparoscopic gastrectomy use increased from 6% in 2012 to 82% in 2021 nationally.
• No significant difference in postoperative outcomes was found within the LOGICA RCT itself.
• Nationally, laparoscopic gastrectomy was associated with significant reductions in overall, severe, and cardiac complications post-trial.

Conclusions:

• The LOGICA RCT successfully promoted the safe dissemination of laparoscopic gastrectomy throughout the Netherlands.
• A robust quality assurance program within the RCT was key to facilitating national adoption.
• This facilitated widespread use reduced patient harm during the learning curve for the technique.