The outcomes from a real-world study have revealed that the Echelon Circular Powered Stapler was associated with a 74% reduction in anastomotic leak rates (1.8% vs. 6.9%) and a 44% reduction in 30-day inpatient hospital readmission rates (6.1% vs.10.8%) after colorectal surgery, compared with manual circular staplers. The study, ‘Outcomes associated with the use of a new powered circular stapler for left‑sided colorectal reconstructions: a propensity score matching‑adjusted indirect comparison with manual circular staplers’, published in Surgical Endoscopy, shows the Echelon Circular Powered Stapler is just as effective in reducing life-threatening and costly surgical complications in real-world surgical practice, according to the authors.
“The data is very positive in terms of postoperative complications and intraoperative events and ease of use, specifically related to the deployment of the circular powered stapler,” said study co-author, Dr Patricia Sylla, a colorectal surgeon and Associate Professor of Surgery at Mount Sinai Hospital in New York. “While anastomotic leaks are a complex problem with various contributing factors, the results of this study highlight the important role that the surgical stapler can play to reduce the potential for complications in colorectal surgery.”
For this real-world study, the authors gathered data from the Echelon Circular clinical trial (165 patients) and the Premier Healthcare database (1,348 manual circular patients) for a matching adjusted indirect comparison of patients who underwent left-sided colorectal resection. Outcomes included 30-day readmission rates; length of stay (LOS) for the index admission; rates of anastomotic leak, pelvic abscess, ileus/small bowel obstruction, infection, bleeding and stoma creation.
After matching, the ECP trial cohort had statistically significant lower rates of 30-day inpatient readmission (6.1% vs. 10.8%, p=0.019), anastomotic leak (1.8% vs. 6.9%, p<0.001), ileus/small bowel obstruction (4.8% vs. 14.7%, p<0.001), infection (1.8% vs. 5.7%, p=0.001) and bleeding (1.8% vs. 9.2%, p<0.001) during the index admission or within 30 days thereafter. In addition, conversions were more prevalent in the historical cohort than the ECP trial cohort (4.2% ECP vs. 10.2% historical, p=0.001).
The authors reported no statistically significant differences in rates of pelvic abscess, stoma creation or LOS were found between the two cohorts. Three subsequent sensitivity analyses (to address the difference in conversion rates) found largely consistent results, with loss of statistical significance for inpatient admission in some cases.
“The results of this study well exceeded our expectations and deserve strong consideration by the surgical community,” said Sanjoy Roy, Senior Director, Global Health Economics and Market Access, Ethicon, Inc. and a co-author of the latest real-world study. “The evidence, along with the innovation in design and performance, supports the possibility of this device raising the standard of care in the hands of surgeons.”
Overall, the study authors concluded that the ECP trial cohort had lower risks of several surgical complications and 30-day readmissions, compared with a retrospectively established historical cohort for whom manual circular staplers were used. However, they cautioned that the findings of this study should not be interpreted as being additive across surgical complications, but rather understood in the context of their close relationships with one another, and further controlled prospective clinical studies are needed to confirm the validity of this finding.
“The reductions in anastomotic leaks associated with the Echelon Circular are so profound, not only in this study, but in previous ones, a closer look at stapler selection for colorectal surgery is warranted,” said Dr Ron Landmann, Section Chief of Colon and Rectal Surgery at Baptist MD Anderson Cancer Center in Jacksonville, FL, who was not involved in the study. “It could lead to a change in standard surgical practice and improved patient outcomes.”
Further information
To access this study, please click here
コメント