The Science of Stapling: Staple Form.

Surgical stapling has evolved significantly over time, with the primary goal of improving patient outcomes. This study describes the technological advancements in surgical stapling from the perspective of staple and cartridge design, assessing the impact of staple design when it changes from the traditional B form (also known as 2D staple form) to a three-dimensional form (known as 3D staple form). The change in configuration helps compress a larger surface area of the tissue. The 3D configuration is designed to optimize compression not only underneath each staple but also across staples and multiple staple lines, including both stapled and unstapled regions of the tissue. By achieving more evenly distributed compression throughout the staple line, there is potential for reduced leak paths. The study demonstrates that the 3D staple form in surgical stapling results in more evenly distributed compression. In the future, this advanced technology should seamlessly integrate into emerging systems such as the surgical robot, enabling continued progress in surgical instrumentation and ultimately in surgical care.

A Comparison of the Preclinical Performance of the Echelon™+ Stapler with Thunderbird Reloads to Two Commercial Endoscopic Surgical Staplers.

Background: Design of surgical staplers continues to advance with more consistent staple formation that can lead to higher leak pressures and lower rates of leak along the staple line. This study was performed to compare the Ethicon Echelon™+ Stapler with Thunderbird reloads to two other currently available commercial staplers, Reach Anzhi and Fulbright Lunar with corresponding reloads. Methods: The rate of malformed staples for three staplers was determined in porcine stomach (3.0-3.3 mm thickness) via CT scanning. Staple line air leak pressures in bronchial tissue (3.0-3.3 mm) and fluid leak pressures in colon (1.3-1.7 mm) were measured and compared to a standard success criterion for both tissues. Results: The rate of malformed staples in gastric tissue for Echelon+ was more than 90% lower than for the two other commercial staplers (p < 0.001). In bronchus, Echelon+ had 56% higher air leak pressures than Reach Anzhi (p < 0.001) and was not significantly different from Fulbright Lunar. In colon, Echelon+ had over twice the fluid leak pressures of the comparators (p < 0.001). Conclusion: The Echelon+ Stapler with Thunderbird reloads exhibited a low rate of malformed staples, and its staple lines withstood high leak pressures in both thick and thin tissues. Clinical studies are needed to confirm that these observed benefits carry over into actual practice.

An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes.

BACKGROUND: For thirty years, the Harmonic scalpel has been used for precise dissection, sealing and transection. There are numerous meta-analyses on individual surgical procedures with Harmonic, but no overarching review covering all the areas. This umbrella review seeks to summarize the clinical results from the use of Harmonic across surgical fields and broadly quantify its effects on patient outcomes. METHODS: MEDLINE, EMBASE, and Cochrane Databases were searched for meta-analyses (MAs) of randomized controlled trials (RCTs) comparing Harmonic devices to conventional techniques or advanced bipolar (ABP) devices. For each procedure type, the most comprehensive MAs were evaluated. RCTs not already analysed in a MA were also included. Operating time, length of stay, intraoperative blood loss, drainage volume, pain, and overall complications were evaluated, and the methodological quality and certainty of evidence were assessed. RESULTS: Twenty-four systematic literature reviews were identified on colectomy, hemorrhoidectomy, gastrectomy, mastectomy, flap harvesting, cholecystectomy, thyroidectomy, tonsillectomy, and neck dissection. There were also 83 RCTs included. In every MA evaluated, Harmonic devices were associated with either statistically significant or numerical improvements in every outcome compared with conventional techniques; most MAs reported a reduction in operating time of ≥ 25 min. Harmonic versus ABP device MAs in colectomy and thyroidectomy showed no significant differences in outcomes. CONCLUSION: Across surgical procedures, Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall complications compared to conventional techniques. Additional studies are required to assess differences between Harmonic and ABP devices.

Improving Performance and Access to Difficult-to-Reach Anatomy with a Powered Articulating Stapler.

Background: Modern surgical staplers should provide precise placement and transection, especially in tight spaces and on thick tissue. Ideally, a stapler would move to accommodate variations in the tissue and anatomy instead of having to move the tissue around to fit the stapler. This study was undertaken to evaluate the performance characteristics of the new Echelon 3000 Stapler (ECH3). Use of the ECH3 was compared to another marketed stapler, including tests for access, seal strength, staple formation in thick tissue, and end effector stability. Methods: Pelvic anatomy measurements were used to construct a virtual model of a Low Anterior Resection (LAR). Monte Carlo simulations were performed on the staplers to compare the probability of completing a transection with one or two firings. Using water infusion of stapled porcine ileum, pressure at first leak and percentage of leaks at critical pressures were measured. Rate of malformed staples was measured in thick tissue. End effector stability while firing and under moderate pressure were compared between staplers. After use, surgeons were surveyed on the functionality of the device. Results: ECH3 had a markedly higher probability of completing an LAR transection in one or two firings than the comparator stapler. Median initial leak pressure of stapled ileum was significantly higher, and rate of leaks was lower at 40 and 50 mmHg. ECH3 had fewer malformed staples for both 3.3- and 4.0-mm thick tissue. The end effector exhibited less angular movement during firing, and less deflection under a moderate load. Surgeons agreed the ECH3 provided precise placement and easy one-handed operation. Conclusion: The Echelon 3000 Stapler demonstrated improved access capability, tighter seals, fewer malformed staples, and greater end effector stability. These advantages were recognized by surgeons who evaluated the use of the device preclinically.

Intraoperative Measures to Reduce the Risk of COVID-19 Transmission During Minimally Invasive Procedures: A Systematic Review and Critical Appraisal of Societies' Recommendations.

BACKGROUND: The coronavirus 2019 pandemic and the hypothetical risk of virus transmission through aerosolized CO2 or surgical smoke produced during minimally invasive surgery (MIS) procedures have prompted societies to issue recommendations on measures to reduce this risk. The aim of this systematic review is to identify, summarize and critically appraise recommendations from surgical societies on intraoperative measures to reduce the risk of severe acute respiratory syndrome coronavirus 2 transmission to the operative room (OR) staff during MIS. METHODS: Medline, Embase, and Google Scholar databases were searched using a search strategy or free terms. The search was supplemented with searches of additional relevant records on coronavirus 2019 resource websites from Surgical Associations and Societies. Recommendations published by surgical societies that reported on the intraoperative methods to reduce the risk of severe acute respiratory syndrome coronavirus 2 transmission to the OR staff during MIS were also reviewed for inclusion. Expert opinion articles were excluded. A preliminary synthesis was performed of the extracted data to categorize and itemize the different types of recommendations. The results were then summarized in a narrative synthesis. RESULTS: Thirty-three recommendation were included in the study. Most recommendations were targeted to general surgery (13) and gynecology (8). Areas covered by the documents were recommendations on performance of laparoscopic/robotic surgery versus open approach (28 documents), selection of surgical staff (13), management of pneumoperitoneum (33), use of energy devices (20), and management of surgical smoke and pneumoperitoneum desufflation (33) with varying degree of consensus on the specific recommendations among the documents. CONCLUSIONS: While some of the early recommendations advised against the use of MIS, they were not strictly based on the available scientific evidence. After further consideration of the literature and of the well-known benefits of laparoscopy to the patient, later recommendations shifted to encouraging the use of MIS as long as adequate precautions could be taken to protect the safety of the OR staff. The release and implementation of recommendations should be based on evidence-based practices that allows health care systems to provide safe surgical and medical assistance.

A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers.

BACKGROUND: Staple line reinforcement (SLR) is a popular tool used by surgeons to increase staple line strength and improve peri-operative hemostasis. However, currently marketed buttress materials require special attention in attachment to the staple anvil and cartridge and may come loose during typical maneuvering of stapling procedures. We have evaluated a new SLR that has an attachment material that affixes buttress across the entire anvil and cartridge face to prevent slipping, twisting, sliding and/or bunching. METHODS: In benchtop and preclinical testing, the new buttress material (ECHELON ENDOPATH™ Staple Line Reinforcement) was compared to a commercially available SLR for physical characteristics, including strength, absorption, security on the anvil and cartridge during stapler manipulation, impact on the tissue healing response and tissue abrasion. The two SLR's were also compared to a staple line without buttress for hemostasis. RESULTS: The new SLR was 180% stronger initially and maintained a greater strength for up to 14 days of exposure to an in vitro solution (p≤0.001), even though it was lighter and exhibited a faster rate of degradation. The new buttress material maintained complete adherence to the anvil and cartridge throughout tissue manipulation, whereas the commercial product lost substantial coverage in 72% of samples. Both SLR's provided superior hemostasis to the non-buttress control, with minimal impact on tissue healing or abrasion. CONCLUSION: Because the new buttress material comes with attachment material affixed across the entire anvil and cartridge face of the stapler and maintains coverage during manipulations, it should be much easier to use. The physical characteristics of the new SLR were as good as or better than current product that requires the buttress to be applied to the cartridge and anvil. In addition, the new SLR is similar in hemostasis to standard products and superior to stapling without the use of buttress. Further research is needed to determine whether these preclinical benefits carry over into a clinical setting.

Effect of safety education on classmates of injured children: a prospective clinical trial.

We hypothesized that using the teachable moment associated with an injured classmate, school-aged children would demonstrate improved retention of injury prevention education. The injured child's class and one control with presentation class received an injury prevention presentation. Prospective evaluation was performed using pre, immediate post, and 1-month posttesting. Immediately following the presentation, 83% of classes in both groups demonstrated significant improvement in test scores. At 1 month, 100% of the injured child's and only 66% of control with presentation classrooms maintained significant improvements. This unique program results not only in immediate but also in long-term retention of injury prevention information.

Development, implementation and evaluation of a unique African-American faith-based approach to increase automobile restraint use.

OBJECTIVE: Despite generalized intervention programs, restraint use among African Americans remains below national levels, especially among children. This study describes the development and implementation of a community participatory faith-based youth injury prevention program. METHODS: Through a partnership with the African-American faith-based community and our injury prevention group, a unique multigenerational intervention program was developed targeting motor vehicle restraint use. Once developed, the program was initially evaluated by comparing outcomes between control and intervention churches. The main objective was to observe adult and pediatric restraint use before and after program implementation. RESULTS: Overall, there was excellent recognition and participation in the program. Following program implementation, significant improvements were observed in restraint use compared to control churches. In particular, there was a 72% reduction in unrestrained children, a 25% increase in children being secured in the rear-seat position and a nearly 20% increase in driver restraint use. CONCLUSIONS: The development and implementation of a culturally sensitive intervention program can significantly improve restraint use in a minority population. Partnering with the community in all phases of the program is essential to its success.