Robotics and Laparoscopy Are Similarly Safe Approaches for Hiatal Hernia and Heller Myotomy Repair
Awshah S, Mhaskar R, Abdul-Rahman FD, et al. Robotics vs Laparoscopy in Foregut Surgery: Systematic Review and Meta-Analysis Analyzing Hiatal Hernia Repair and Heller Myotomy. J Am Coll Surg. 2024; in press.
This article reported results of a systematic review of the literature to compare outcomes of laparoscopic and robotic approaches for two foregut surgical procedures, hiatal hernia repair (HHR) and Heller myotomy (HM). Published studies were selected using multiple databases, and risk of bias was assessed using the Cochrane-ROBINS-I tool. Twenty-two acceptable studies that included 196,339 patients were selected for analysis.
Robotic HHR was associated with significantly shorted length of hospital stay, fewer conversions to open procedures, and lower overall rates of morbidity. Robotic procedures for performance of HM had significantly lower risk of esophageal perforation and reinterventions. Operative time was longer for robotic procedures. The authors emphasized that prospective, randomized trials are needed given the low quality of the available comparative research. Detailed data on the relationship between surgeon experience and outcomes of robotic procedures were not always available and cost analyses comparing the two approaches were not regularly reported.
The authors concluded that robotic and laparoscopic approaches for HHR and HM have similar safety profiles and robotic procedures may offer some advantages.
Advances in Neoadjuvant Therapy Help Improve Outcomes after Pancreatectomy
Cass SH, Tzeng CD, Prakash LR, et al. Trends Over Time in Recurrence Patterns and Survival Outcomes after Neoadjuvant Therapy and Surgery for Pancreatic Cancer. Ann Surg. 2024.
Cass and coauthors reported long-term trends in recurrence and patient survival following resection of pancreatic ductal adenocarcinoma over a 20-year interval (1998–2018) to determine the influence of neoadjuvant and adjuvant therapies on these outcomes.
A retrospective cohort (n = 727) of patients treated in a single cancer center were included; rates of recurrence and survival were recorded in three 6-year time intervals. Use of neoadjuvant chemotherapy increased steadily over the study interval; chemotherapy regimens changed over time with more than 80% of patients receiving FOLFORINOX or gemcitabine in the 2021–2018 interval. Sites of recurrence and incidence of recurrence (66%) remained stable; most recurrences were diagnosed in the first 2 years following resection. Recurrences in the first year following resection decreased in the later intervals and 3-year survival increased from 7% during the 1998–2004 interval to 20% during the 2012–2018 interval. Increased post-recurrence survival was the main cause of improved overall survival.
The authors concluded that neoadjuvant therapy and improved multimodal adjuvant therapies for recurrence were associated with improved outcomes for patients with pancreatic cancer who underwent resection with curative intent.
Researchers Recommend Use of Term “Clinically Significant” when Findings Should Change Practice
Gikandi A, Hallet J, Koerkamp BG, et al. Distinguishing Clinical from Statistical Significances in Contemporary Comparative Effectiveness Research. Ann Surg. 2024; in press.
Puhan MA, Clavien PA. Is Statistical Significance Alone Obsolete? – Let's Turn to Meaningful Interpretation of Scientific and Real-World Evidence on Surgical Care. Ann Surg. 2024 in press.
Domenghino A, Walbert C, Birrer DL, et al. & the Outcome4Medicine Consensus Group. Consensus Recommendations on How to Assess the Quality of Surgical Interventions. Nat Med. 2023;29:811-822.
Recommendations for changes in management of surgical conditions are usually based on comparative effectiveness research that has shown a “statistically significant” improvement in outcomes for a treatment compared to a “standard” approach.
Unfortunately, a significant proportion of these recommended changes do not result in long-term cure of the treated disease or durable patient benefits; recognition of this shortcoming has stimulated leaders in surgical research to encourage use of “clinically significant” outcomes to support recommendations for changing approaches to surgical patient management.
“Clinically significant” is defined as outcomes such as: long-term cure of the target disease, meaningful reductions in postoperative morbidity and improvements in quality of life (as quantified by standard scales), and measurable improvement in patient-reported outcomes (PROMS) as well as positive patient reported experience measures (PREMS). Documentation of these outcomes in surgical research studies can lead to calculation of the minimal clinically important difference (M[C]ID) which can be used to support practice changing conclusions.
The article by Gikandi and coauthors reported findings from a systematic review of the surgical literature; the study included 307 published articles (162 clinical trials and 145 observational studies). The analysis showed that recommendations for changes in clinical practice were mostly based on “statistical significance.” Only 8.5% of the included articles used “clinical significance” in supporting recommendations for changes in clinical practice. The authors concluded that most authors of surgical research studies use “statistical significance” rather than “clinical significance” to support practice change recommendations.
In the editorial that accompanies the article, Puhan and Clavien recommended that authors use “clinical significance” as defined in the expert consensus recommendations article by Domenghino and coauthors (reference listed above) when reporting research that could lead to changes in surgical practice.
All three of these publications contain important, clinically relevant information; surgeons are encouraged to review the full content of the articles.
