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

Abstract

Background This was a retrospective, matching-adjusted indirect comparison of clinical outcomes between patients from a single-arm trial of the ECHELON CIRCULAR™ Powered Stapler (ECP) and those from a historical cohort of patients who underwent left-sided colorectal resection using conventional manual circular staplers, extracted from the Premier Healthcare Database. Methods Patients in the ECP trial cohort were propensity score matched to those in the historical cohort through nearest neighbor matching. 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. Results The study included 168 patients in the ECP trial cohort and 4544 patients in the historical cohort; 165 ECP trial patients were matched to 1348 historical cohort patients. After matching, conversions were more prevalent in the historical cohort than the ECP trial cohort (4.2% ECP vs. 10.2% historical, p = 0.001). Relative to the historical cohort, 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. No statistically significant differences in rates of pelvic abscess, stoma creation, or LOS were found between the two cohorts. Three sensitivity analyses to address the difference in conversion rates yielded largely consistent results, with loss of statistical significance for inpatient admission in some cases. This study is limited by its potential for differences in unmeasurable factors between the ECP trial and historical cohorts. Conclusions In this study, the ECP trial cohort had lower incidence proportions of several surgical complications as compared with the historical cohort. Further controlled prospective clinical studies are needed to confirm the validity of this finding.

Economic Analysis of Leak Complications in Anastomoses Performed with Powered versus Manual Circular Staplers in Left-Sided Colorectal Resections: A US-Based Cost Analysis

“…The current budget impact model is based on a previously completed MAIC analysis that demonstrates the superior comparative effectiveness of ECP vs manual circular staplers with respect to fewer anastomotic leaks as well as lower rates of 30-day readmissions. 26 The present model demonstrates the potential savings associated with use of ECP, which offset the higher price of the device, and provides an economic rationale for the adoption of the ECHELON CIRCULAR™ Powered Stapler in patients undergoing left-sided colorectal reconstructions.…”

“…Several model limitations should be noted, however. Although real-world evidence was leveraged for the model where available, the inputs for the rates of anastomotic leak complication with ECP were from an MAIC analysis 26 which used data inputs from both a prospective clinical study (ECP group) 25 and retrospective hospital billing data analysis (SOC). It is possible that patients in a clinical trial setting may experience fewer complications due to trial protocols that require increased monitoring and patient management.…”

“…25 Using data from the ECP trial, a matching-adjusted indirect comparison (MAIC) was recently conducted to compare clinical and healthcare utilization outcomes of patients using ECP with those of a propensity score-matched retrospective standard of care (SOC) control cohort from a real-world clinical practice population. 26 Patients treated with ECP had statistically significant lower 30-day incidence proportions of several surgical complications and 30-day readmissions. Given that these surgical complications carry substantial economic ramifications in the hospital setting, the objective of the current study was to estimate the cost impact of using ECP versus manual circular staplers to US hospitals for the complication of anastomotic leak.…”

Indirect comparison between powered and manual circular staplers for left-sided colorectal anastomoses: clinical and economic outcomes in China

“…Pla-Marti et al in a retrospective study reported a statistically significant lower rate (1.7%) of anastomotic leak among left-sided stapled colorectal anastomosis procedures using ECP, as compared to 11.8% using manual circular staplers [ 4 ]. An indirect comparison between the ECP cohort from a single-arm trial and a matched historical cohort of patients who used manual staplers also presented a lower anastomotic leak rate (1.8% vs. 6.9%), as well as other complication rates and 30-day readmission [ 9 ]. The economic benefit of ECP is anticipated because of the avoidance of complications and readmission.…”

Prevention of anastomotic leakage using a polyglycolic acid sheet in double-stapling technique anastomosis for rectal surgery

“…Therefore, various surgical techniques have been devised. For example, an evaluation of the intestinal blood flow using indocyanine green (ICG) fluorescent [ 6 , 7 ], sufficient mobilization of the left colon including splenic flexure for tension-free anastomosis [ 8 , 9 ], improvements in stapling devices [ 10 , 11 ] and the placement of a transanal tube for decompression of anastomosis [ 12 , 13 ]. However, anastomotic leakage in rectal surgery remains one of the most serious postoperative complications.…”