From evidence to a day-to-day laparoscopic colectomy
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- Hanisch, E. & Ziogas, D.E. Surg Endosc (2011) 25: 985. doi:10.1007/s00464-010-1262-0
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High-quality evidence for incorporating new medical devices, technology, and surgical techniques into public health care with safety, efficiency, and consideration for cost-effectiveness requires analysis . Laparoscopic techniques have revolutionized surgery. Indeed, minimally invasive approaches that can dramatically improve a patient’s outcomes have been evolved rapidly over the past two decades.
But how fast can new surgical techniques (e.g., laparoscopic colectomy) be translated into a wide clinical use when evidence-based processes including comparative-effectiveness research (CER) have been completed? This question about laparoscopic colectomy in the United States is highlighted by Singla et al.  in the March issue of Surgical Endoscopy.
Using the Nationwide Inpatient Sample (NIS, 1998–2006), the authors identified a total of 209,769 patients who underwent laparoscopic or open elective colon resection. The hospitals in which colectomies were performed were divided according to hospital volume into equal thirds, with the highest third defined as high volume and the lower two-thirds defined as low volume. The primary end point was the use of laparoscopy after adjustment for patient and hospital covariates.
Colorectal cancer, one of the major cancer types, suggests a major problem not only in the United States but also worldwide. Although Singla et al.  in their report do not provide precise data on the benign or malignant type of the disease, most colon resections are performed because of colon cancer. Over recent decades, open surgery has been standardized, including adequate resection of the primary tumor and regional lymph nodes, resulting in complete resection with no macroscopic or microscopic evidence of residual tumor (R0 resection).
Is laparoscopic R0 colectomy feasible, safe, equally effective in terms of oncologic outcomes, and favorable regarding quality of life (QOL) compared with open surgery? In this evidence-based medicine era and U.S. health reform, requirements and rules for approving new diagnostic and therapeutic procedures have become more intensive, with emphasis given to more robust evidence.
In deciding whether to pay for new medical technologies, the Centers for Medicare and Medicaid Services (CMS) is becoming more specific about its requirements for evidence of improved health outcomes in the Medicare population . A recent example involves the CMS decision not to cover computed tomographic (CT) colonography because of insufficient evidence for screening benefits .
The heightened emphasis on evidence will almost certainly continue as more people recognize that the old approach is unsustainable. The $1.1 billion for comparative effectiveness research (CER) included in the American Recovery and Reinvestment Act underscores an emerging appreciation that we need better mechanisms for generating relevant evidence and for enabling patients, clinicians, and payers to use that evidence in decision making [3–5]. The best tools of CER are thought to be randomized controlled trials (RCTs) and metaanalysis .
Under the rules and requirements set by the U.S. Food and Drug Administration, CER, and CMS, what is the grade of evidence supporting laparoscopic surgery for gastrointestinal cancer, particularly colon cancer? Results from RCTs and a metaanalysis have demonstrated the equal safety and efficiency in terms of oncologic outcomes and a QOL superiority of laparoscopic colectomy over open colectomy for patients with stages 1 to 3 colon cancer . Rapidly accumulating results from small RCTs and retrospective studies suggest benefits for rectal cancer patients treated by laparoscopic or robotic-assisted rectal cancer resections and gastric cancer patients treated by laparoscopic gastrectomy, but the results of ongoing or new phase 3 RCTs should be awaited before robust conclusions are drawn [7–12].
What is the current grade of evidence for laparoscopic surgical treatment of gastric cancer? To date, conclusive evidence for laparoscopic gastrointestinal cancer surgery has emerged only for laparoscopic colectomy used to treat patients with colon cancer.
Based on high-quality evidence favoring laparoscopic over open colectomy, what are the acceptance and performance rates for laparoscopic colectomy? In the study by Singla et al. , overall, only 8,407 of colon resections (4%) were performed using laparoscopy. The authors found that high-volume hospitals used laparoscopy more often than low-volume hospitals (5.2 vs. 3.4%). After adjustment for covariates using multivariate analysis and propensity scores, analysis showed that patients with private insurance and those in the highest income bracket were more likely to receive laparoscopy (p < 0.0009). High-volume hospitals were more likely to perform laparoscopically assisted colectomy than low-volume hospitals.
Singla et al.  concluded that socioeconomic differences appear to exist between high- and low-volume hospitals in the use of laparoscopy in the United States and that laparoscopic colectomy is more often performed in high-volume hospitals. Although the study by Singla et al.  is limited by its retrospective nature, the proportion of laparoscopic colectomy in the United States still is small even in high-volume hospitals. Safe and effective laparoscopic colectomy for cancer requires a R0 for both primary tumor and regional lymph nodes, which is time consuming and requires high-volume surgeons with expertise in laparoscopic technique. Perhaps this rate is higher in highly specialized cancer centers that attract surgeons and clinicians with high expertise in cancer treatment.
The latest advances in new technologies promise improvement besides improved QOL through laparoscopically or robotically assisted colorectal resections as well as improvement in oncologic outcomes through high-throughput DNA-sequencing technologies for cancer patients. Indeed, these massively parallel sequencing techniques allow optimism for the identification of causal cancer genome mutations, which may lead to a new generation of biomarkers and biologic agents [13–29].
Ernst Hanisch and Dimosthenis E. Ziogas have no conflicts of interest or financial ties to disclose.