Key result
Crossover from minimally invasive to open surgery in randomized controlled trials was significantly associated with increased 30-day mortality (β = 0.125, p=0.033), anastomotic leak rate, and early complications.
Why the study?
Does crossover from minimally invasive to open surgery increase 30-day mortality and complications in patients undergoing surgery for gastrointestinal cancer?
Meta-Analysis (n=11,625)
Yes
Does crossover from minimally invasive to open surgery increase 30-day mortality and complications in patients undergoing surgery for gastrointestinal cancer?
Effect estimate: β = 0.125 (95% CI 0.012-0.238)
p-value: p=0.033
Crossover from minimally invasive to open surgery in gastrointestinal cancer trials is associated with increased 30-day mortality and complications, highlighting the need for surgeon credentialing and careful patient selection to optimize RCT validity.
Demands strategies to minimize crossover in future trials; challenges validity of existing RCTs in GI cancer surgery.
BACKGROUND: Randomized controlled trials (RCTs) inform clinical practice and have provided the evidence base for introducing minimally invasive surgery (MIS) in surgical oncology. Crossover (unplanned intraoperative conversion of MIS to open surgery) may affect clinical outcomes and the effect size generated from RCTs with homogenization of randomized groups. OBJECTIVES: Our aims were to identify modifiable factors associated with crossover and assess the impact of crossover on clinical endpoints. METHODS: A systematic review was performed to identify all RCTs comparing MIS with open surgery for gastrointestinal cancer (1990-2017). Meta-regression analysis was performed to analyze factors associated with crossover and the influence of crossover on endpoints, including 30-day mortality, anastomotic leak rate, and early complications. RESULTS: Forty RCTs were included, reporting on 11,625 patients from 320 centers. Crossover was shown to affect one in eight patients (mean 12.6%, range 0-45%) and increased with American Society of Anesthesiologists score (β = + 0.895; p = 0.050). Pretrial surgeon volume (β = - 2.344; p = 0.037), composite RCT quality score (β = - 7.594; p = 0.014), and site of tumor (β = - 12.031; p = 0.021, favoring lower over upper gastrointestinal tumors) showed an inverse relationship with crossover. Importantly, multivariate weighted linear regression revealed a statistically significant positive correlation between crossover and 30-day mortality (β = + 0.125; p = 0.033), anastomotic leak rate (β = + 0.550; p = 0.004), and early complications (β = + 1.255; p = 0.001), based on intention-to-treat analysis. CONCLUSIONS: Crossover in trials was associated with an increase in 30-day mortality, anastomotic leak rate, and early complications within the MIS group based on intention-to-treat analysis, although our analysis did not assess causation. Credentialing surgeons by procedural volume and excluding high comorbidity patients from initial trials are important in minimizing crossover and optimizing RCT validity.
No takes yet. Share an insight, caveat, or question.
Garas et al. (2017) conducted a meta-analysis in Gastrointestinal cancer (n=11,625). Crossover from minimally invasive to open surgery vs. Lower crossover rates was evaluated on 30-day mortality (β = 0.125, 95% CI 0.012-0.238, p=0.033). Crossover from minimally invasive to open surgery in randomized controlled trials was significantly associated with increased 30-day mortality (β = 0.125, p=0.033), anastomotic leak rate, and early complications.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: