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

Author(s)

ABSTRACT WITHDRAWN

OBJECTIVES : The intraoperative performance of the ECHELON CIRCULAR™ Powered Stapler (ECP) during left-sided colectomy procedures was recently evaluated in a single-arm trial. The present study is a retrospective, matching-adjusted indirect comparison of clinical outcomes between patients from the ECP trial 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 at a 1:10 variable-ratio with a caliper. Matching covariates included age, sex, Hispanic ethnicity, insurance type, diabetes, hypertension, surgical approach, indication for surgery, teaching vs. non-teaching hospital, and hospital bed size category. 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 4,544 patients in the historical cohort; 165 ECP trial patients were ultimately matched to 1,348 historical cohort patients. Relative to the historical cohort, the ECP trial cohort had statistically significant lower rate 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. Sensitivity analyses accounting for conversion yielded nearly identical results.

CONCLUSIONS : In this propensity score matching-adjusted indirect comparison, the ECP trial cohort had lower incidence proportions of several surgical complications and 30-day readmissions as compared with the historical cohort. Further controlled prospective clinical studies are needed to confirm the validity of this finding.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PGI6

Topic

Clinical Outcomes, Medical Technologies

Topic Subcategory

Comparative Effectiveness or Efficacy, Medical Devices

Disease

Gastrointestinal Disorders, Medical Devices, Oncology, Surgery

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