Impact of the novel powered circular stapler on risk of anastomotic leakage in colorectal anastomosis: a propensity score-matched study

Plá-Martí, Vicente; Martín-Arévalo, José; Moro‐Valdezate, David; García-Botello, Stephanie; Mora-Oliver, Isabel; Gadea-Mateo, Ricardo; Cózar-Lozano, Coral; Espi-Macías, Alejandro

doi:10.1007/s10151-020-02338-y

Cited by 34 publications

(42 citation statements)

References 20 publications

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“…Ultimately, the findings of the present study must not be interpreted as being additive across surgical complications, but CI confidence interval, MID mean incremental difference (ECP trial cohort minus historical cohort), NS not statistically significant *In the historical cohort, complications were measured using ICD-10-CM/PCS codes from the index admission, or during inpatient, outpatient, or emergency room visits occurring within 30 days of index admission at the same hospital; In the ECP trial, complications were measured during multiple visits including the surgery and postoperative recovery through discharge visit, the follow-up visit at 28 ± 14 days after the procedure date, or during any unplanned visits occurring between rather understood in the context of their close relationships with one another. Notably, the present study's findings related to anastomotic leak are consistent with those reported by Pla-Marti and colleagues [5]. They reported that among patients undergoing left-sided colorectal anastomosis, anastomotic leak was observed in 11.8% of 218 patients (5.8% requiring reoperation) in whom manual circular staplers were used and 1.7% of 61 patients in whom the ECP was used (P = 0.022).…”

Section: Discussionsupporting

confidence: 92%

“…First, after matching, 165 of 168 patients were retained in the ECP trial cohort. Upon review of the matched ECP trial cohort outcomes, 3 of the 165 patients in the ECP trial had anastomotic leak, as compared with 4 of the 168 patients reported by Herzig et al 5 Under the hypothetical situation that the single patient with anastomotic leak who was not matched during the matching procedure had been retained in the sample, the findings related to anastomotic leak would have changed minimally (2.4% ECP trial cohort vs. 6.9% historical cohort, mean incremental difference = -4.5%; 95% CI = -72%, 1.8%; P = 0.001). Second, of the 93 patients who experienced anastomotic leak in the historical control cohort, 40 (43.0%) received the initial diagnosis after discharge from the index admission.…”

Section: Discussionmentioning

confidence: 94%

“…A recently published retrospective, single-center study by Pla-Marti and colleagues [ 5 ] compared the risk of anastomotic leak after left-sided colorectal anastomosis when using the ECP (61 patients) versus manual circular staplers (218 patients). They reported anastomotic leak in 11.8% of patients in the manual circular stapler group and 1.7% of patients in the ECP group ( p = 0.022).…”

mentioning

confidence: 99%

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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

et al. 2021

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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.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 94%

mentioning

confidence: 99%

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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

et al. 2021

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“… 23 In a propensity score matched cohort study (119 cases manual circular stapler [MCS] versus 60 ECP stapler), anastomotic leak was observed in 14 (11.8%) patients in the MCS group and in 1 (1.7%) patient in the ECP group (P = 0.022). 24 Most recently, a prospective, post-market, open label, single-arm multicenter clinical study of ECP at 12 sites in the USA and Europe (November 28, 2017 through January 15, 2020) reported adequate performance for creation of anastomoses in left-sided colon resection procedures, few technical issues, a favorable safety profile, and ease of use for creation of left-sided anastomoses as reported by operating surgeons. 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.…”

Section: Introductionmentioning

confidence: 99%

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

Pollack¹,

Johnston²,

Petraiuolo³

et al. 2021

CEOR

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Purpose To estimate the cost impact of using the ECHELON CIRCULAR™ Powered Stapler (ECP) compared with manual circular staplers (standard of care, SOC) among patients undergoing colectomy procedures that involve left-sided anastomosis. Methods A US hospital-based budget impact model was developed to estimate the impact of ECP in reducing the surgical complication of anastomotic leak. The incremental acquisition cost of ECP vs SOC was compared to the net potential savings from reduced complication costs. The model was based on complication rates from a recently published matching-adjusted indirect comparison (MAIC) that compared clinical and healthcare utilization outcomes of patients using ECP with those of a propensity score-matched retrospective SOC control cohort from a real-world clinical practice population. The model assessed total cost, average length of stay (LOS), proportion of patients with a non-home discharge, and all-cause readmission. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were conducted to evaluate the robustness of the model assumptions and inputs. Results Despite a higher device cost of $412 for ECP compared with $298 for a manual stapler, annual savings due to avoided complications with ECP was $53,987 for anastomotic leak, assuming 100 procedures per year with each type of circular stapler. ECP also helped to avoid 27 LOS days, 0.38 readmissions and 0.22 non-home discharges. Sensitivity analyses around potential drivers of costs established the robustness of economic savings with the use of ECP – with annual savings being most impacted by the probability of anastomotic leak complication in the DSA. Conclusion This model demonstrates that among patients undergoing left-sided colectomy procedures, the incremental cost of using the ECHELON CIRCULAR™ Powered Stapler instead of a manual circular stapler was offset by the savings from lowered incidence and cost of management of anastomotic leaks in the hospital setting.

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“…Anastomotic leakage after rectal surgery is a serious complication, with a recently reported incidence of 3.9–13.1% [ [1] , [2] , [3] , [4] , [5] , [6] , [7] ]. To prevent anastomotic leakage, various attempts have recently been performed during surgery, such as the usage of a transanal decompression tube (TDT), the application of a polyglycolic acid sheet to reinforce staple lines of the rectal stump and/or the use of a powered circular stapler [ [4] , [5] , [6] , [7] , [8] , [9] ].…”

Section: Introductionmentioning

confidence: 99%

Colon perforation caused by transanal decompression tube after laparoscopic low anterior resection: A case report

Hiraki

Tanaka

Okuyama

et al. 2021

International Journal of Surgery Case Reports

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Highlights The effectiveness of a transanal decompression tube to prevent anastomotic leakage after rectal surgery is widely accepted. A rare complication of colonic perforation due to a transanal decompression tube may occurred. The relationship between the tip of the transanal decompression tube, the intestine and the sacrum might be important.

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Impact of the novel powered circular stapler on risk of anastomotic leakage in colorectal anastomosis: a propensity score-matched study

Cited by 34 publications

References 20 publications

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

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

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

Colon perforation caused by transanal decompression tube after laparoscopic low anterior resection: A case report

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