Two-row, three-row or powered circular stapler, which to choose when performing colorectal anastomosis? A systematic review and meta-analysis.

PURPOSE: Three types of circular staplers can be used to perform a colorectal anastomosis: two-row (MCS), three-row (TRCS) and powered (PCS) devices. The objective of this meta-analysis has been to provide the existing evidence on which of these circular staplers would have a lower risk of presenting a leak (AL) and/or anastomotic bleeding (AB). METHODS: An in-depth search was carried out in the electronic bibliographic databases Embase, PubMed and SCOPUS. Observational studies were included, since randomized clinical trials comparing circular staplers were not found. RESULTS: In the case of AL, seven studies met the inclusion criteria in the PCS group and four in the TRCS group. In the case of AB, only four studies could be included in the analysis in the PCS group. The AL OR reported for PCS was 0.402 (95%-confidence interval (95%-CI): 0.266-0.608) and for AB: 0.2 (95% CI: 0.08-0.52). The OR obtained for AL in TRCS was 0.446 (95%-CI: 0.217 to 0.916). Risk difference for AL in PCS was - 0.06 (95% CI: - 0.07 to - 0.04) and in TRCS was - 0.04 (95%-CI: - 0.08 to - 0.01). Subgroup analysis did not report significant differences between groups. On the other hand, the AB OR obtained for PCS was 0.2 (95% CI: 0.08-0.52). In this case, no significant differences were observed in subgroup analysis. CONCLUSION: PCS presented a significantly lower risk of leakage and anastomotic bleeding while TRCS only demonstrated a risk reduction in AL. Risk difference of AL was superior in the PCS than in TRCS.

Intragastric free cancer cells may be attached to automatic staplers during anastomosis in patients with gastric cancer.

BACKGROUND: Automatic staplers are often used to reconstruct the digestive tract during surgeries for gastric cancer. Intragastric free cancer cells adhering to automatic staplers may come in contact with the laparoscopic port area and progress to port site recurrence. This study aimed to investigate the presence/absence of cancer cells adhering to automatic staplers during gastric cancer surgery using cytological examinations. We further determined the positive predictive clinicopathological factors and clinical implications of free cancer cells attached to automatic staplers. METHODS: This study included 101 patients who underwent distal gastrectomy for gastric cancer. Automatic staplers used for anastomosis in gastric cancer surgeries were shaken in 150 ml of saline solution to collect the attached cells. Papanicolaou stains were performed. We tested the correlation between cancer-cell positivity and clinicopathological factors to identify risk factors arising from the presence of attached cancer cells to the staplers. RESULTS: Based on the cytology, cancer cells were detected in 7 of 101 (6.9%) stapler washing fluid samples. Univariate analysis revealed that circular staplers, type 1 tumors, and positive lymph nodes were significantly associated with higher detection of free cancer cells adhering to staplers. No significant differences in other factors were detected. Of the seven cases with positive cytology, one developed anastomotic recurrence. CONCLUSIONS: Exfoliated cancer cells adhered to the automatic staplers used for anastomoses in 6.9% of the staplers used for distal gastrectomies in patients with gastric cancer. Staplers used for gastric cancer surgeries should be handled carefully.

Development of an Electrical Impedance Tomography Coupled Surgical Stapler for Tissue Characterization.

OBJECTIVE: This study explores the feasibility of coupling Electrical Impedance Tomography (EIT) to a standard-of-care laparoscopic surgical stapler, stapler+EIT, with the long-term goal of enabling intraoperative tissue differentiation for tumor margin detection. METHODS: Two custom printed-circuit-board-based electrode arrays with 60 and 8 electrodes, respectively, matching the stapler geometry, served as the jaws of an electrode-integrated surrogate stapler+EIT device. The device was evaluated through a series of simulations and bench-top imaging experiments of agar-gel phantoms and bovine tissue samples to evaluate the technique and determine optimal imaging parameters. RESULTS: Electrodes localized to only one jaw (the 60-electrode side) of the stapler outperformed a dual-jaw distribution of electrodes. Using this one-sided electrode array, reconstructions achieved an Area-Under-the-Curve (AUC) ≥ 0.94 for inclusions with conductivity contrasts of ≥30% for any size considered on measured agar-gel tests, and an AUC of 0.80 for bovine tissue samples. CONCLUSION: A stapler+EIT algorithm has been tuned and evaluated on challenging phantom tests and demonstrated to produce accurate reconstructions. SIGNIFICANCE: This work is an important step in the development of a surgical stapler+EIT technique for margin assessment.

Sutures in general surgery. New materials and advice.

The suture thread used in digestive surgery must have several characteristics, including resistance to tension until the anastomosis coalescence, rapid absorption to avoid complications, biocompatibility and ease of handling. The preference is for monofilament polymers as they offer greater guarantees in biliary-digestive anastomoses. Suturing with synthetic polymers and mechanical devices such as staplers are the most suitable techniques. It is believed that staplers may become the gold standard technique in robotic surgery based on their experience and experimental data. In general, the goal is to use materials that minimize the risk of post-operative complications and offer maximum reliability in the anastomosis. KEY WORD: Suture material, Stapler.

Risk of anastomotic leakage with two-row versus three-row manual circular staplers in colorectal anastomosis: a U.S. cohort study.

PURPOSES: To compare the risk of anastomotic leak (AL) between Ethicon manual circular staplers (two-row) versus Medtronic EEA™ circular stapler with Tri-Staple™ technology (three-row) and between Medtronic EEA™ circular stapler with DST™ Series technology (two-row) versus Tri-Staple™ technology. METHODS: A retrospective cohort study was conducted in adult patients who underwent a left-sided colorectal surgery 2019-2022 in U.S. Premier Healthcare Database to assess the risk of AL within 30 days post-index procedure. The study devices were Ethicon manual circular staplers, Medtronic EEA™ circular stapler with DST™ technology, and Medtronic EEA™ circular stapler with Tri-Staple™ technology. RESULTS: Across 447 hospitals, the cumulative incidences (95% confidence intervals [CI]) of AL within 30 days post-index procedure were 7.78% (6.91-8.74%) among 8337 patients in the Ethicon manual circular stapler cohort, 7.54% (6.87-8.27%) among 7928 patients in the Medtronic EEA™ circular stapler with DST™ technology cohort, and 8.19% (6.57-10.07%) among 1306 patients in the Medtronic EEA™ circular stapler with Tri-Staple™ technology cohort. Comparative analyses revealed no difference comparing Ethicon manual circular staplers with Medtronic EEA™ circular staplers with Tri-Staple™ technology (risk ratio [RR], 0.72; 95% CI, 0.52-1.01) or comparing Medtronic EEA™ circular staplers with DST™ technology to Tri-Staple™ technology (RR, 0.75; 95% CI, 0.53-1.06). CONCLUSION: In this analysis of a large cohort of patients undergoing a left-sided colorectal surgery from a U.S. hospital database, the risk of AL observed with manual two-row circular staplers was similar to that seen with three-row devices. This study affirms the safety of manual two-row circular staplers in colorectal anastomosis.

The effect of circular stapler size on anastomotic stricture formation in colorectal surgery: A propensity score matched study.

BACKGROUND: Small circular staplers possess the advantage of being relatively easy to use when compared to larger circular staplers. However, there is some contention as to whether the use of small circular staples in colorectal surgery increases the incidence of anastomotic strictures. This study aimed to determine whether the frequency of anastomosis site stricture formation differs depending on stapler size when performing anastomosis in colorectal surgery. METHODS: Patients who underwent surgery for colon or rectal disease between June 1, 2009, and December 31, 2021, and who had circular staplers used for the formation of intestinal anastomoses post colectomy were included in our study. Propensity score matching with a 1:1 ratio using logistic regression was performed. The primary outcome was the anastomotic stricture rate, and the secondary outcome was total anastomotic complications. RESULTS: A total of 875 patients who were operated on by surgeons using 28/29-mm and 25-mm circular staplers were included. After propensity score matching, 106 patients were assigned to each group. Anastomotic strictures occurred in two cases (1.9%) from the 25-mm group and in four cases (3.8%) from the 28/29-mm group. There were no statistically significant differences between the two groups (p = 0.683). Anastomotic complications were observed in two cases (1.9%) from the 25-mm group and in six cases (5.7%) from the 28/29-mm group; no statistically significant differences were found (p = 0.280). CONCLUSION: Circular stapler size does not influence anastomotic stricture formation in colorectal surgery.

Estudio comparativo entre circuncisión mecánica y manual en población pediátrica: ¿una alternativa a la técnica convencional? / Comparative study of mechanical vs. manual circumcision in the pediatric population: An alternative to the conventional technique?

Objetivos: La circuncisión es una de las intervenciones quirúrgicas más realizadas en cirugía pediátrica. Aunque la técnica con suturamanual (SMAN) se considera el gold standard, recientemente se handesarrollado dispositivos de sutura mecánica (SMEC) de fácil manejo ycon mejores resultados postoperatorios en la población adulta. El objetivo de nuestro estudio es comparar el tiempo quirúrgico y la incidencia decomplicaciones postoperatorias entre ambas técnicas en nuestro ámbito.Material y métodos: Estudio retrospectivo de pacientes circuncidados en nuestro centro entre octubre 2021 y diciembre 2022. Se analizóel tiempo quirúrgico y las complicaciones observadas en los primeros14 días postoperatorios (edema, hematoma, dehiscencia), en funciónde la técnica empleada (SMAN vs SMEC) y la edad de los pacientes(< 12 y ≥ 12 años). Resultados: Se incluyeron 173 pacientes (147 SMAN, 26 SMEC).El tiempo quirúrgico medio fue significativamente menor en los pacientes con SMEC, tanto en < 12 años (16 min vs. 10 min, p= 0,002) comoen ≥ 12 años (23 min vs 12 min, p< 0,001). En cuanto a las complicaciones, los pacientes con SMEC del grupo ≥ 12 años presentaron menortasa de dehiscencia de sutura (23,5% vs 0%, p< 0,001), sin observarsediferencias significativas en el grupo de menor edad. Conclusiones: La circuncisión con SMEC es una técnica sencillay eficaz, que precisa un tiempo quirúrgico más reducido que la suturamanual, independientemente de la edad. Presenta menor tasa de complicaciones en los niños de mayor edad (≥ 12 años), por lo que se planteacomo una alternativa válida a la técnica clásica.(AU)

Objective: Circumcision is one of the most common surgical procedures in pediatric surgery. Even though manual suture (MANS) isregarded as the gold standard technique, easy-to-use mechanical suture(MECS) devices have been recently developed, with better postoperative results in the adult population. The objective of our study was tocompare the operating time and incidence of postoperative complicationsbetween both techniques in our environment.Materials and methods: A retrospective study of patients undergoing circumcision in our institution from October 2021 to December 2022was carried out. Operating time and complications observed in the first14 postoperative days (edema, hematoma, dehiscence) were analyzedaccording to the technique used (MANS vs. MECS) and patient age(< 12 and ≥12 years old).Results: 173 patients (147 MANS, 26 MECS) were included.Mean operating time was significantly lower in MECS patients, bothin patients < 12 years old (16 min vs. 10 min, p= 0.002) and in patients≥12 years old (23 min vs. 12 min, p< 0.001). Regarding complications,MECS patients ≥12 years old had a lower rate of suture dehiscence(23.5% vs. 0%, p< 0.001), with no significant differences in the youngergroup. Conclusions: MECS circumcision is a simple and effective technique involving shorter operating times than MANS circumcision, regardless of age. It has a lower rate of complications in older children (≥12years), which means it stands as a valid alternative to the conventionaltechnique.(AU)

Impact of powered circular stapler on anastomotic leak after anastomosis to the rectum: a propensity score matched study.

PURPOSE: The aim of the present study is to assess the impact of Echelon Circular™ powered stapler (PCS) on left-sided colorectal anastomotic leaks and to compare results to conventional circular staplers (CCS). METHODS: A single center cohort study was carried out on 552 consecutive patients, who underwent laparoscopic colorectal resection and anastomosis to the rectum between December 2017 and September 2022. Patients who underwent powered circular anastomosis to the rectum were matched to those who had a conventional stapled anastomosis using a propensity score matching. Main outcomes were anastomotic leak (AL) rate, anastomotic bleeding, and postoperative outcomes. RESULTS: After adjusting cases with propensity score matching, two new groups of patients were generated: 145 patients in the PCS and 145 in the CCS. The two groups were homogeneous with respect to demographics and comorbidities on admission. Overall, AL occurred in 21 (7.3%) patients. No significant differences were observed with respect to AL (5.5% in PCS vs 9% in CCS; p = 0.66), fistula severity (p = 0.60) or reoperation rate (p = 0.65) in the two groups in study. A higher rate of anastomotic bleeding was observed in the CCS vs PCS (5.5% vs 0.7%, p = 0.03). At univariate analysis performed after propensity score matching, stapler diameter ≥ 31mm and age ≥ 70 years were the only variable significantly associated with anastomotic leak (p = 0.001 and p = 0.031; respectively). CONCLUSIONS: The powered circular stapler has no impact on AL, while it could affect bleeding rate at the anastomotic site.

End-to-end stapled technique for Kono-S anastomosis.

PURPOSE: Our aim was to develop a Kono-S anastomotic technique using surgical staplers. METHODS: Two patients underwent stapled Kono-S anastomosis, one via abdominal and one transanal approach. RESULTS: The approach for an abdominal and transanal stapled Kono-S anastomosis is detailed. CONCLUSION: The Kono-S anastomosis can be safely configured using common surgical staplers.

Evaluating Performance of Circular Staplers Using Comparative Test Methods for Evidence-Based Surgery.

BACKGROUND: Circular stapler anastomosis is a common surgical procedure. Despite technological advancements, anastomotic leak remains a postoperative concern. Assessment of new technologies is impeded by variations in test methods and analysis, precluding outcome reproducibility and direct comparisons of results across studies. The development of robust and reproducible preclinical test methods is critical to accelerating stapling technology advancements. METHODOLOGY: Leak pressure, staple line perfusion and security, and device removal force were quantified for triple-row (Tri-staple EEA, TriEEA) and double-row staplers (Echelon Circular Powered, ECP). Leak and perfusion testing were performed in vivo. Device removal force and staple line security testing were performed with synthetic medium using an Instron. Data were analyzed using unpaired student's t-test or Kruskal-Wallis test, with statistical significance defined as P < .05. RESULTS: Leak pressure was 73% higher in TriEEA vs ECP (P = .016). TriEEA staple line failure force was lower than ECP at 40 and 50 mmHg (P = .001 and P = .023, respectively). Perfusion to the staple line was higher (148%) for TriEEA than for ECP (P = .003) and the force required to remove the device from its stapled anastomosis was 78% lower for TriEEA than for ECP (P < .001). DISCUSSION/CONCLUSIONS: This report addresses a primary limitation in stapling research by presenting novel methodologies which enhance clinical relevance and provide sufficient detail for reproduction by independent investigators. These methods are applied to a comparison between triple-row and double-row staplers to demonstrate utility of new test methods in assessing key technology design features.

Biologically inspired gastrointestinal stapler design: "Getting to Zero" complications.

As next generation stapling devices enter the marketplace with robotic adaptations, tri-staple technology, preloaded reinforcement materials, etc., in this perspective piece we assert that a "refresh" in our understanding of the mechanisms of action of these devices is needed. While much attention has been paid to explain the mechanical features of one device versus another, it seems that little to no attention is being paid to understand how an intestinal anastomosis responds biologically to the variations in their use and design. Here we will review various aspects of gastrointestinal stapling in the context of emerging technology in the field and expose the gaps in knowledge that exist regarding the effect of gastrointestinal stapling on the biology of healing.

Is staple line reinforcement still needed on contemporary staplers? A benchtop analysis.

BACKGROUND: Staple line reinforcement (SLR) is commonly used in bariatric surgeries to reduce leaks and bleeds. With the evolution of staplers, the need for buttressing with the latest surgical stapling technology is in question. The efficacy of GORE® SEAMGUARD® (G-SLR) to improve staple line strength based on an established measure of burst pressure was evaluated. A benchtop test on synthetic tissue evaluated the pressure required for staple line leak across surgical staplers with and without G-SLR. METHODS: Staple lines on a consistent thickness synthetic bowel were pressurized to the point of failure (burst pressure) among Ethicon®, Intuitive®, and Medtronic® surgical staplers with and without G-SLR. Burst pressure and leak location (through the staple line [TTSL] or through the staple [TTS], on the anvil or cartridge side) were recorded. Visual confirmation of a leak concluded each test. RESULTS: The pooled mean burst pressure for G-SLR was greater (p < 0.05) by 0.494 pounds/square inch compared with no reinforcement with no meaningful differences among staplers. Leak failures were primarily TTS (91.7%) and equally distributed between reinforcement groups with more leak failures on the cartridge side with G-SLR and on the anvil side for non-SLR group. Leaks occurred across the length of staple lines with no discernable pattern. CONCLUSION: Employing a buttressing material strengthens the staple line, as measured by burst pressure, and may reduce the risk for staple line failure. This benchtop study of G-SLR with three commonly used surgical staplers demonstrated a significant increase in burst pressures among the studied stapling devices.

Real-life introduction of powered circular stapler for esophagogastric anastomosis: cohort and propensity matched score study.

Anastomotic leakage after esophagectomy is one of the most feared complications, which results in increased morbidity and mortality. Our aim was to evaluate the impact of a powered circular stapler on complications after esophagectomy with intrathoracic anastomosis for esophageal cancer. Between May 2019 and July 2021, all consecutive oesophagectomies for cancer with intrathoracic anastomosis in a high-volume center were included in this retrospective study. Surgeons were free to choose either a manual or a powered circular stapler. Preoperative characteristics and postoperative complications were recorded in a prospective database, according to EsoData. Propensity score matching (age, body mass index, Eastern cooperative oncology group (ECOG) performance and neoadjuvant therapy) was conducted to reduce potential confounding. We included 128 patients. Powered and manual circular staplers were used in 62 and 66 patients, respectively. Fewer anastomotic leakages were observed with the powered stapler group (OR = 7.3 (95%CI: 1.58-33.7); [3.2% (n = 2) vs 19.7% (n = 13), respectively; p = 0.004]). After propensity score matching, this remained statistically significant (OR = 8.5 (95%CI: 1.80-40.1); [4.1% (n = 2) vs 20.4% (n = 10), respectively; p = 0.013]). Additionally, anastomotic diameter was significantly higher with the powered stapler (median: 29 mm (63.3%) vs 25 mm (57.1%), respectively; p < 0.0001). There was no significant difference in comprehensive complication index (p = 0.146). A decreased mean length of stay was observed in the powered stapler group (11.1 vs 18.7 days respectively; p = 0.022). Postoperative anastomotic leakage after esophageal resection was significantly reduced after the introduction of the powered circular stapler, consequently resulting in a reduced length of stay. Further evaluation on long-term strictures and quality of life are warranted to support these results.

Impact of the vertical division of the rectum on the decrease in reloading of the endostapler for a complete division in colorectal cancer

Background: Despite several improvements in surgical techniques, the intracorporeal division of the distal end of the rectum is still challenging, particularly when it is too deep in a narrow pelvis. Even though it helps avoid spillage, the double-stapling technique (DST) raises concerns regarding safety and anastomotic leakage if multiple stapler firings are essential to complete the rectal division. Objective: To assess the feasibility of vertically dividing the rectum and its impact in reducing the number of reloads essential for that division in non-low rectal cancer patients undergoing total mesorectal excision (TME). Materials and Methods A retroprospective study. Results: From January 2017 to November 2021, a total of 123 patients with sigmoid and rectal cancers were enrolled in the present study; their data were collected and analyzed, and 21 patients were excluded. The remaining sample of 102 subjects was composed of 47 male (46%) and 55 female (54%) patients with a median age of 54 years (range: 30 to 78 years). Only 1 reload was enough to complete the rectal division in 82 (80.39%) cases, and 2 reloads were used in the remaining 20 (19.61%) patients. Anastomotic leakage was clinically evident in 4 cases (3.9%). No statically significant difference was observed when firing one or two staplers. No 30-day mortality was recorded in this series. Conclusion: Our early experience indicates that this type of division has a real advantage in terms of decreasing the number of reloads needed and, in turn, lowering the incidence of anastomotic leakage after partial mesorectal excision (PME) or TME when applied with proper patient selection. (AU)

Comparison of pressure resistance of double-rows and triple-rows circular stapler in rectal double stapling technique: In vitro study.

BACKGROUND: Anastomotic leak after gastrointestinal anastomosis is a serious complication. Anastomotic failure depends on various parameters. The aim of our study was to evaluate the pressure resistance of a new device, EEA™ circular stapler with Tri-Staple™ technology 28 mm Medium/Thick (Triple-rows circular stapler; TCS) compared with EEA™ circular stapler with DST series™ technology 28 mm, 4.8 mm staples (double-rows circular stapler; DCS). PATIENTS AND METHODS: We performed 30 anastomoses (DSC: 15, TCS: 15) of DST with porcine colon model in vitro. We performed following 3 comparative experiences; Experiment 1: observation of staple shape with a colonoscopy, Experiment 2: comparison of the pressure resistance, Experiment 3: comparison of leakage points. RESULTS: There was no hypoplasia of staples and the shapes were well-formed by colonoscopy. The leakage pressure of DCS was 19.6 ±â€…4.4 mm Hg (mean ±â€…standard deviation) and that of TCS was 38.6 ±â€…10.2 mm Hg (mean ±â€…standard deviation). There was a significantly difference between 2 groups (P < .001). 12 cases of DCS (80%) and 10 cases of TCS (66.7%) had leakages from Circular stapler point. 2 cases of DCS (13.3%) and 5 cases of TCS (33.3%) had leakages from Crossing points. Only 1 case of DCS had leakages from Dog ear point (6.7%). There was no significantly difference in leakage site between 2 groups (P = .195). CONCLUSIONS: TSC showed high pressure resistance during DST compared with that of DCS. It was suggested that TCS may contribute to the reduction of anastomotic leakage rate.

The Viscoelastic Behavior of Soft Tissues Must be Accounted for in Stapler Design and Surgeon Technique.

BACKGROUND: Since its adoption as a surgical technique over a half-century ago, stapling has continually undergone improvements, both in the devices used and in our understanding of tissue mechanics. To best design and use stapling devices, it is beneficial to have an intimate knowledge of the response of tissue to compression and stapling dynamics. This paper provides the relevant background in the field of biomechanics, and in particular addresses the viscoelastic behavior of soft tissues under compression. Biomechanics of Stapling: The change in shape of a solid, or strain, is related to the load applied, or stress. Biological tissues are known to have non-linear relationships between stress and strain, and generally the relationships are anisotropic (dependent upon direction). Further complicating matters, there is typically a time-dependency to the relationship for compression and recovery, resulting in viscoelastic behavior. Hence both the amount and rate of compressive force applied can be expected to impact the outcome of stapling. DISCUSSION: The growth of the laparoscopic use of staples has increased the difficulty of device design, as precise control of compression is problematic in extended length staplers. Progressive firing along the cartridge and multi-stage compression have both been found to be beneficial in providing the uniform force needed to produce well-formed staples. Such technical advances can reduce stresses within the stapler, preventing deformation of the stapler arm and undesirable strain in the tissue. Current research includes understanding the effects of changing the rate of compression on staple formation with the hope that further improvements can be achieved in this ever-fruitful method of tissue apposition.