Surgery for CS is highly successful for pituitary-dependent CS and most ACTH-independent adrenal causes. Bilateral total adrenalectomy can also provide effective palliation from the ravages of hypercortisolism in patients with ectopic ACTH syndrome and for those who have failed transsphenoidal surgery. Unfortunately, to date, adrenocortical carcinomas are rarely cured. Future successes with this disease will likely depend on a better understanding of tumor biology, more effective adjuvant therapies and earlier detection. Clearly, IPSS, advances in cross-sectional imaging, along with developments in transsphenoidal and laparoscopic surgery, have had the greatest impact on today's management of the complex patient with CS.
Objective
To compare outcomes between the two latest innovations in powered stapling technology, the ECHELON FLEX™ GST system (GST) and the Signia™ Stapling System (SIG), among patients undergoing sleeve gastrectomy for obesity.
Patients and Methods
Using the Premier Healthcare Database of US hospital discharge records, we selected patients undergoing inpatient sleeve gastrectomy with dates of surgical admission between March 1, 2017 (SIG launch), and December 31, 2018. Outcomes measured during the surgical admission included in-hospital hemostasis-related complications (bleeding/transfusion; primary outcome), leak, total hospital costs, length of stay (LOS), and operating room time; 30-, 60-, and 90-day all-cause inpatient readmissions were also examined. We used 1:1 cardinality matching to balance the GST and SIG groups on numerous patient and hospital/provider characteristics, allowing a maximum standardized mean difference (SMD) ≤0.05 for all matching covariates. Generalized estimating equations (GEE) accounting for hospital-level clustering were used to compare the study outcomes between the GST and SIG groups.
Results
Of the 5573 identified cases, there were 491 patients in each group (982 total) after matching. The observed incidence proportion of hemostasis-related complications during the surgical admission was lower in the GST group as compared with the SIG group (3 events/491 [0.61%] vs 11 events/491 [2.24%]; odds ratio [SIG=reference] = 0.28, 95% CI=0.13–0.60, P=0.0012). Differences between the GST and SIG groups were not statistically significant for leak, total hospital costs, LOS, OR time, and all-cause inpatient readmission at 30, 60, and 90 days.
Conclusion
In this retrospective study of 982 matched patients undergoing sleeve gastrectomy, the ECHELON FLEX™ GST system was associated with a lower rate of hemostasis-related complications as compared with the Signia™ Stapling System. Further controlled prospective studies are needed to confirm the validity of this finding.
Background:
An advanced bipolar (ABP) tissue sealer designed for division of major vessels in open procedures was evaluated in a prospective post-market study. The objective was to provide clinical data for assessment of vessel transection, hemostatic performance and ease of use of the ABP device during open colectomy, gynecologic, and thoracic operations.
Materials and methods:
The ABP test device was used in colectomy (n = 36), gynecologic (n = 44), and thoracic (n = 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1–4, defined as follows: Grade1, no bleeding; Grade 2, minor bleeding with no intervention; Grade 3, minor bleeding requiring touchup with the test device or monopolar cautery; and Grade 4, significant bleeding requiring intervention with any additional hemostatic product. The primary performance measure was the percentage of vessels that achieved hemostasis grades ≤3. The primary safety endpoint was the summarization of all ABP device-related adverse events (AEs).
Results:
For all three procedure groups together, 302 (96.2%) of 314 total vessel transections were scored as hemostasis grades ≤ 3, including 270 (86.0%) that were rated Grade 1. Twelve transections (3.8%) were Grade 4, which included 9 vessels transected in the gynecologic group and 3 in the thoracic group. Three subjects experienced a total of 4 device-related AEs, consisting of hematoma, hypotension, procedural pain, and superficial thermal burn. All 4 device-related AEs were mild in severity.
Conclusion:
The advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures.
Trial registry number:
ClinicalTrials.gov, NCT034411.
Highlights:
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