Electrospun Polymeric Fiber Systems Inoculated with Cyanoacrylate Tissue Adhesive: A Novel Hemostatic Alternative during Open Surgery.

Natural-based and synthetic tissue adhesives have attracted extensive attention in the last two decades for their ability to stabilize uncontrolled bleeding instances. However; these materials present several drawbacks during use that scientists have tried to minimize in order to optimize their usage. This study comprises the development of a novel wound dressing, combining the excellent properties of polylactic acid (PLA) non-woven textile, as substrate, obtained through electrospinning, and a cyanoacrylate-based (CA) tissue adhesive, for rapid hemostatic action. Thus, the fabrication of electrospun PLA membranes at three different PLA concentrations, the design and manufacturing of the support system and the production of surgical patches were carried out. SEM and FT-IR methods were employed for analyzing the morphology as well as the indicative markers for the shelf life evolution of the obtained patches. PLA fibers with well-defined structures and a mean diameter varying between 4.6 and 7.24 µm were obtained with the increase of the concentration of the PLA solutions. In vivo tests on a rat model as well as peeling tests for good patch adhesion on liver fragments harvested from the test animals, with a limit for the strength of the liver tissue of 1.5 N, were carried out. The devices exhibited excellent adhesion to the parenchymal tissue and a long enough shelf life to be used with success in surgical procedures, also facilitating prompt hemostatic action.

Epigenetic and Molecular Alterations in Obesity: Linking CRP and DNA Methylation to Systemic Inflammation.

Obesity is marked by excessive fat accumulation in the adipose tissue, which disrupts metabolic processes and causes chronic systemic inflammation. Commonly, body mass index (BMI) is used to assess obesity-related risks, predicting potential metabolic disorders. However, for a better clustering of obese patients, we must consider molecular and epigenetic changes which may be responsible for inflammation and metabolic changes. Our study involved two groups of patients, obese and healthy donors, on which routine analysis were performed, focused on BMI, leukocytes count, and C-reactive protein (CRP) and completed with global DNA methylation and gene expression analysis for genes involved in inflammation and adipogenesis. Our results indicate that obese patients exhibited elevated leukocytes levels, along with increased BMI and CRP. The obese group revealed a global hypomethylation and upregulation of proinflammatory genes, with adipogenesis genes following the same trend of being overexpressed. The study confirms that obesity is linked to systematic inflammation and metabolic dysfunction through epigenetic and molecular alterations. The CRP was correlated with the hypomethylation status in obese patients, and this fact may contribute to a better understanding of the roles of specific genes in adipogenesis and inflammation, leading to a better personalized therapy.

The Value of Preoperative C-Reactive Protein to Albumin Ratio as a Prognostic Biomarker in Colon Cancer Patients.

Inflammatory acute phase proteins have been reported to play a crucial role in cancer progression. Various hematologic and inflammatory markers and scores, such as the lymphocyte-to-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic inflammation score (SIS), prognostic nutritional index (PNI), Glasgow prognostic score, and, more recently, the Naples prognostic score, have been reported as significant prognostic markers. The aim of this prospective study was to evaluate the prognostic significance of the C reactive protein-to-albumin ratio (CAR) in patients with colon cancer. Materials and Methods: We conducted a prospective observational study on a series of patients who underwent curative surgery for colon cancer. The C reactive protein-to-albumin ratio was determined preoperatively, and we evaluated the correlations between the CAR and various clinical and pathological parameters, as well as the correlation with Overall and Relapse-free survival. Furthermore, we compared the accuracy of the CAR with that of the Naples score. Results: One hundred and ten patients were included in the study. We set 0.4927 as the cut-off value for the CAR according to a receiver operating characteristic curve analysis. Based on the cut-off value, patients were divided into a low CAR group and a high CAR group. The preoperative CAR exhibited statistically significant correlation with tumor volume, T and N stage, number of positive lymph nodes, and grade of tumor differentiation. We also demonstrated a positive correlation between high CAR values and a higher Naples score (p = 0.0005), even when a subgroup analysis was performed for each group individually. Conclusions: The preoperative CAR is a useful prognostic marker in patients with colon cancer. These results may help to design strategies to personalize targeted management approaches among colon cancer patients.

Anastomotic Leakage after Gastrectomy for Gastric Cancer.

Anastomotic leakage (AL) constitutes a prominent cause of significant morbidity following gastrectomy for gastric cancer. The manifestation of AL typically occurs within 7 to 10 days post-surgery, with reported incidence rates of 5.8-6.7% for open gastrectomy and 3.3-4.1% for laparoscopic gastrectomy. Various predisposing risk factors have been identified, including the individual nutritional status (excluding obesity) and preoperative corticotherapy. Interestingly, the administration of neoadjuvant therapies appears to reduce the AL occurrence. In the context of distal gastrectomies, the rates of AL are comparable between laparoscopic, robotic, and open approaches. The total gastrectomies have higher AL rate compared to distal gastrectomies, which are considered the preferred approach. Prophylactic drainage measures have not demonstrated efficacy in preventing AL. As for postoperative management, conservative treatment is indicated for patients presenting with mild clinical symptoms and increased inflammatory blood tests. This approach involves fasting, enteral or parenteral nutrition, administration of antibiotics, and percutaneous drainage. For small AL, endoscopic therapies such as stents, vacuum therapy, clips, suturing devices, and injections are appropriate treatment options. In cases of high-volume fistulas, severe sepsis or failure of previous therapies, surgical reoperation becomes the ultimate solution.

Adverse Outcome of Two-Staged Breast Reconstruction: More Than One Culprit.

BACKGROUND: Two-stage prosthetic breast reconstruction with initial insertion of a tissue expander followed by change-over to an implant after a period of inflation has become a well-established option in breast reconstruction. Our aim was to analyze the feasibility of two-stage breast reconstruction in our center by following the surgical technique, number of complications and associated risk factors. PATIENTS AND METHODS: We studied 91 patients who underwent skin sparring mastectomy and tissue expander placement in our surgical unit, between January 2017 and December 2021. Axillary surgery was performed in all patients. We collected data on age, smoker status, breast size, comorbidities, tumor characteristics, neoadjuvant treatment and surgical intervention details. RESULTS: Skin necrosis (12.08%) and seroma (16.48%) were the most common complications. 7.69% of the patients required reintervention. Patients underwent delayed reconstruction after more than 6 months in 69.7% of the cases, while the overall reconstruction rate was 86.08%. Smoker status, an increased body mass index, comorbidities, neoadjuvant treatment, type of incision and location of the implant were the main factors that led to adverse outcomes. CONCLUSIONS: Tissue expanders are a viable option for reconstruction; however, we observed a higher incidence of skin complications in smokers and in cases where periareolar incision was used.

Cyanoacrylate Adhesives Used for Topical Hemostasis A Systematic Review.

Introduction: In this systematic review the topical hemostatic properties of Cyanoacrylate Adhesives (CA) have been studied. Material and Method: Four major scientific databases (Embase, Scopus, PubMed, and Web of Science) were inquired, retrieving reviews and meta-analysis studies, clinical trials, experimental studies, and case reports that presented data regarding topical hemostasis and CA. English written articles, published in the last 10 years were collected. The last search was performed on the 1st of August 2023. Risk of bias in the included studies was assessed using study-design specific, evidence-based tools. Results: A summary focused on relevant information of all included studies was drafted and the results of the studies have been synthetized and compared. A total of 42 studies have been included in the review (14 reviews and meta-analysis, 11 clinical trials, 9 experimental studies and 8 case reports). CA exhibited important topical hemostatic capabilities, comparable with other performant hemostatic materials. Although most included studies concluded that CA were potent topical hemostatic agents, the high level of heterogeneity among the studies prevented us from performing a meta-analysis. Conclusion: The results of this review show that CA-based compounds represent an important line of research towards the perfect hemostatic material.

Reduction of Anastomotic Time Through the Use of Cyanoacrylate in Microvascular Procedures.

Background: Ever since the description of the first microvascular anastomosis, numerous alternative methods have been described to the classical approach. Tissue adhesive has shown promising result in previous studies and can be a fast and efficient alternative which still requires more studies to allow its clinical implementation. Methods: A randomized comparative experimental study was conducted on rats' femoral arteries and an end-to-end anastomosis was performed in order to compare 2 anastomosis techniques. In one group, a simple interrupted suture was utilized, whereas in the second group a combination between fewer sutures and tissue adhesive was used. The anastomotic time, total operative time, blood flow velocity before, immediately after and 48 hours after the procedure, as well as an independent grading of the anastomosis immediately after the procedure were performed. Magnetic resonance imaging (MRI) was performed in order to assess the degree of stenosis. After euthanasia, histology and scanning electron microscopy (SEM) were performed on the vessels in order to assess possible complications. Results: A total of 24 anastomoses were performed, of which 12 with a classic technique and 12 with an adhesive technique. All the anastomoses were patent with a significant reduction of anastomotic and total operative time. The grading of the anastomoses showed better results in the classic suture group. The blood flow velocities were not statistically significant between the 2 groups. On MRI there was one stenotic anastomosis, whereas histology and SEM showed more complications on the adhesive group. Conclusion: Anastomotic times were significantly lower with a non-significant trend toward more thrombotic complications in the adhesive group. Further improvement of the glue properties and refinement of the technique will likely make it a viable alternative to interrupted suturing in the future.

Historique: Depuis que la première anastomose microvasculaire a été décrite, de nombreuses méthodes ont été utilisées en plus de la méthode classique. L'adhésif tissulaire a donné des résultats prometteurs dans des études antérieures et peut représenter une solution rapide et efficace qui devra faire l'objet de plus d'études avant d'être adoptée en clinique. Méthodologie: Les chercheurs ont mené une étude expérimentale aléatoire et comparative sur des artères fémorales de rat. Ils ont effectué une anastomose de bout en bout pour comparer deux techniques d'anastomose. Dans un groupe, une seule suture interrompue a été utilisée, et dans le second, une combinaison d'un moins grand nombre de sutures et d'adhésif tissulaire a été privilégiée. La durée de l'anastomose, la durée totale de l'intervention, la vélocité du débit sanguin avant, immédiatement après et 48 heures après l'intervention, de même que le classement indépendant de l'anastomose immédiatement après l'intervention. L'imagerie par résonance magnétique a permis d'évaluer le degré de sténose. Après l'euthanasie, les chercheurs ont effectué l'histologie et la microscopie électronique sur les vaisseaux pour évaluer les complications possibles. Résultats: Au total, 24 anastomoses ont été exécutées, soit 12 avec la technique classique et 12 avec la technique d'adhésion. Toutes les anastomoses étaient perméables et s'associaient à une réduction importante de la durée de l'anastomose et de l'opération totale. Le classement de l'anastomose a révélé de meilleurs résultats dans le groupe de suture classique. La vélocité du débit sanguin n'était pas statistiquement significative entre les deux groupes. On a constaté une anastomose sténosée à l'imagerie par résonance magnétique, tandis que l'histologie et la microscopie électronique ont révélé plus de complications dans le groupe d'adhésion. Conclusion: La durée de l'anastomose était beaucoup plus courte et présentait une tendance non significative vers un plus grand nombre de complications thrombotiques dans le groupe d'adhésion. Des améliorations des propriétés de la coller et le raffinement des techniques en feront probablement une solution viable pour remplacer les sutures.

Absolute and Functional Iron Deficiency in Colon Cancer: A Cohort Study.

Background and Objectives: Iron is an essential micronutrient for many biological functions and has been found to be intimately linked to cancer biology. Although the effects of increased dietary iron consumption in the development of CRC have been previously investigated in several cohort studies, the available evidence on the involvement of iron deficiency in this process is relatively scarce. Previously published papers did not analyze specific outcomes, such as the presence of biologically aggressive histopathological characteristics, that are associated with the subtypes of iron deficiency. The purpose of this study was to investigate the connection between the development of colorectal cancer and the presence of functional iron deficiency (FID), which is defined as insufficient biological availability of iron in the presence of adequate storage reserves, or absolute iron deficiency (AID), which is defined as severely depleted iron storage levels. Materials and Methods: Our paper represents a single center registry-based cohort study. Iron levels were routinely evaluated upon diagnosis of CRC and the collected data were coupled with patient- and tumor-specific data (2018-2022). Spearman's correlation coefficient and the chi-squared test were used to analyze the association. Results: Out of 129 patients, 75 (58.13%) were anemic. AID was identified in 26.35% of cases and FID was encountered in 51.16% of cases. A statistically significant association between FID and lymphatic invasion was encountered. An analysis of the correlation demonstrated a significant association between anemia and right-sided tumor location. Conclusions: Functional iron deficiency seems to be independently associated with lymphatic invasion. Although a statistically significant correlation with the T or N stage was not demonstrated, the analysis suggested a potential positive relationship between the presence of FID and more aggressive tumor characteristics.

Reduction of the Number of Live Animals Used for Microsurgical Skill Acquisition: An Experimental Randomized Noninferiority Trial.

BACKGROUND: Live animals have been used for decades as one of the many training models for developing surgical skills. Microsurgery in particular relies on training for skill acquisition and maintenance, using live animal models, especially rats (murine models). Efforts are underway to reduce the number of rats sacrificed to achieve this objective. METHODS: A group of students with minimal microsurgical experience, after having gone through a basic microsurgical course, were randomly split into three equal groups, all three groups following a 24-week standard training program based on low- and medium-fidelity training models with standardized murine training days. In addition to the standard training regimen, each participant performed supplementary training on live rats every 4, 6, or 8 weeks. According to the training program, the procedures have been performed on chicken legs, flower petals, and rats, each procedure being blindly assessed and evaluated using validated models and scales. The primary evaluated outcome was the Stanford Microsurgery and Resident Training (SMaRT) scale result of the final rat anastomosis performed by each group, for which the tested hypothesis was one of noninferiority. The secondary outcomes were represented by the final rat anastomosis time, final chicken leg anastomosis result and time, and the final petal score. RESULTS: After the 24th week, no differences were observed between the three groups regarding their microsurgical skills, as measured by the aforementioned surgical outcomes. All participants improved significantly during the study (mean [standard deviation] 19 ± 4 points on the SMaRT scale), with no significant differences between the groups, p < 0.001 for noninferiority. CONCLUSION: A training regimen based on low- and moderate-fidelity models, with the addition of training on a live rat every 8 weeks was noninferior to a training regimen that used a live rat every 6 weeks and also noninferior to a training regimen that used a live rat every 4 weeks.

Non-invasive laparoscopic detection of small tumors of the digestive tract using inductive sensors of proximity.

The precise location of gastric and colorectal tumors is of paramount importance for the oncological surgeon as it dictates the limits of resection and the extent of lymphadenectomy. However, this task proves sometimes to be very challenging, especially in the laparoscopic setting when the tumors are small, have a soft texture, and do not invade the serosa. In this view, our research team has developed a new instrument adapted to minimally-invasive surgery, and manipulated solely by the operating surgeon which has the potential to locate precisely tumors of the digestive tract. It consists of an inductive proximity sensor and an electronic block encapsulated into an autoclavable stainless-steel cage that works in tandem with an endoscopic hemostatic clip whose structure was modified to increase detectability. By scanning the serosal side of the colon or stomach, the instrument is capable to accurately pinpoint the location of the clip placed previously during diagnostic endoscopy on the normal bowel mucosa, adjacent to the tumor. In the current in-vivo experiments performed on large animals, the modified clips were transported without difficulties to the point of interest and attached to the mucosa of the bowel. Using a laparoscopic approach, the detection rate of this system reached 65% when the sensor scanned the bowel at a speed of 0.3 cm/s, and applying slight pressure on the serosa. This value increased to 95% when the sensor was guided directly on the point of clip attachment. The detection rate dropped sharply when the scanning speed exceeded 1 cm/s and when the sensor-clip distance exceeded the cut-off value of 3 mm. In conclusion, the proposed detection system demonstrated its potential to offer a swift and convenient solution for the digestive laparoscopic surgeons, however its detection range still needs to be improved to render it useful for the clinical setting.

Preventing Breast Cancer-Related Lymphedema: Feasibility of Axillary Reverse Mapping Technique.

INTRODUCTION: Our study aimed to determine the feasibility of axillary reverse mapping (ARM) technique, the identification rate of ARM nodes and their metastatic involvement, as well as to identify the factors that influence the identification and metastatic involvement. MATERIAL AND METHODS: In total, 30 breast cancer patients scheduled for axillary lymph node dissection were enrolled in our study. The lymphatic nodes that drain the arm were identified by injecting 1 mL of blue dye in the ipsilateral upper arm; then, the ARM nodes were resected along with the other lymph nodes and sent for histological evaluation. RESULTS: Identification of ARM node was successful in 18 patients (60%) and 22.22% of the identified ARM lymph nodes had metastatic involvement. Patients with identified ARM nodes had a significant lower BMI and a statistically significant relationship between axillary lymph node status and ARM node metastases was proven. Most of ARM lymph nodes (96.3%) were found above the intercostobrachial nerve, under the axillary vein and lateral to the thoracodorsal bundle. CONCLUSIONS: The ARM procedure is easy to reproduce but might not be appropriate for patients with a high BMI. The rate of metastatic involvement of ARM nodes is significant and no factor can predict it, showing that the preservation of these nodes cannot be considered.

Feasibility of oncoplastic surgery in breast cancer patients with associated in situ carcinoma.

PURPOSE: Wide surgical margins are needed in order to treat locally the in situ ductal carcinoma of the breast. Breast conserving surgery using oncoplastic techniques in treating in situ ductal carcinoma can be a good option improving cosmetic and pathological outcome. METHODS: Between January 2019 and July 2019, 76 patients with invasive carcinoma associated with in situ ductal carcinoma were eligible for breast conserving surgery and were admitted to Cluj-Napoca First Surgical Clinic. Patients were divided into two groups, one group with simple lumpectomy and the other group with oncoplastic procedure. RESULTS: 26 patients had oncoplastic surgery while 47 patients underwent simple lumpectomy. Lateral mammoplasty was the most frequent oncoplastic procedure (41.3%). Mean tumor size was 3.19 cm (SD 0.76) in the oncoplastic cohort while in the simple lumpectomy cohort the mean tumor size was 1.20 cm (SD 0.89). Regarding tumor size, better surgical resection margins were obtained using oncoplastic procedure (p=0.051). No difference between groups in terms of perioperative complications was observed (p=0.32). CONCLUSIONS: Breast conserving surgery with oncoplastic techniques are oncologically safe, obtaining better surgical margins in ductal carcinoma in situ.

Genetic and epigenetic mechanisms involved in bariatric surgery.

Morbid obesity (BMI>40 kg/m2) is a challenging health condition with an increasing incidence in the last decades. Conventional therapy which consists in diet and lifestyle interventions, along with pharmaceutical therapy, has a limited effect on morbidly obese patients. In this context, bariatric surgery is the most effective approach, leading to significant weight loss, along with other beneficial effects like type 2 diabetes resolution or improvement of cardiovascular status. The bariatric surgery outcomes can widely vary among individuals, with a significant percentage of patients having small benefits from the operation. These variations may be partially explained by the genetic background of each individual. During the last years, several studies have been conducted in order to determine the genetic and epigenetic factors involved in bariatric surgery outcomes. Many genes involved in different molecular pathways were found to be associated with weight loss after bariatric surgery. Epigenetic studies revealed that genes methylation may be influenced by weight loss interventions. All these findings suggest that there is an intimate connection between genetic and epigenetic factors and the bariatric surgery outcomes. Further studies are required in order to better understand if genetics can be used in order to predict the operation results. KEY WORDS: Bariatric surgery, Body-mass index, Epigenetic, Genetic.

Risk factors for positive sentinel lymph node, lymphatic or hematogenous dissemination over time in patients with cutaneous melanoma.

The aim of the present study was to assess the influence of localization, age or sex and histopathological characteristics upon the chance of developing lymphatic or hematogenous metastatic spread over time, or a positive sentinel lymph node in cutaneous melanoma patients. Patients from the Department of Dermatology, County Emergency Hospital Cluj-Napoca (Cluj-Napoca, Romania), presenting with cutaneous melanoma confirmed histopathologically and a SPECT/CT or lymphoscintigraphic examination to detect the sentinel lymph node, were included in the present study. Our results revealed that Breslow index >2 mm [odds ratio (OR)=4.22, 95% confidence interval (CI) (1.12; 15.93)], presence of ulceration [OR=6.01, 95% CI (1.87; 19.35)], and positive sentinel lymph node [for at least one sentinel lymph node OR=3.58, 95% CI (1.06; 12.04)] were risk factors for hematogenous metastases. All these, except for the Breslow index >2 mm, were demonstrated to be a risk factor for lymphatic spread metastases over time. Ulceration and male sex also represented risk factors for a positive sentinel lymph node, men having a higher risk of developing sentinel lymph nodes than women [adjusted OR=2.27, 95% CI (1.00; 5.13)]. In conclusion, the predictors that influence the occurrence of lymphatic or hematogenous metastases may differ, ulceration and positive sentinel lymph node being common for both types of metastatic spread, while Breslow index being a significant predictor only for hematogenous metastases. Male sex and the presence of ulceration were demonstrated to be significant risk factors for positive sentinel lymph nodes.

Silicone Adenopathy and Intractable Axilary Pain after Breast Implant Augmentation - Case Report.

Introduction: Silicone lymphadenophaty (siliconoma) is a rare complication secondary to breast implant augmentation or breast reconstruction surgery. Although it is usually linked to the age of the implant, the predominant etiology is multifactorial. Herein, we report a case of extensive siliconoma in the axilla in the hope that our experience will contribute to clinical decision making. Case presentation: We report the case of a 41-year-old woman with intense pain in her right axilla 20 years after breast augmentation surgery. Analgesics were of limited use and the pain became debilitating over time. After a thorough physical examination, imaging studies found three central axillary lymph nodes with a "snowstorm" appearance, suggestive of silicone lymphadenopathy. A complete excision of the lessions was performed with resolution of pain on follow-up. Subsequent histological analysis showed lymph nodes containing large doplets of silicone. Conclusions: General and plastic surgeons must remain aware as silicone adenopathy can be causative of anxiety and significant local symptoms among patients. Thorough investigations are needed in order to exclude malignancies and provide an optimal treatment strategy.

Multilayered Porous Titanium-Based 3rd Generation Biomaterial Designed for Endosseous Implants.

This work proposes a novel complex multi-layered material consisting of porous titanium as a substrate and a complex coating consisting of a chitosan film engulfing microsphere loaded with growth factors such as BMP2 (bone morphogenic protein 2) and IGF1 (insulin-like growth factor-1). The microspheres were obtained through deposition of dual layers of calcium cross linked pectin-chitosan/pectin polyelectrolyte onto a BSA (bovine serum albumin) gel core. The multilayer was conceived to behave like a 3rd generation biomaterial, by slow delivery of viable growth factors around implants, and to assist the healing of implantation wound and the development of new vital bone. The biologic effect of the delivery of growth factors was studied in vitro, on MSC-CD1 mesenchymal stem cells, and in vivo, on CD1 mice. Proliferation and differentiation of cells were accelerated by growth factors, especially IGF1 for proliferation and BMP2 for differentiation. In vivo tests analyzed histologically and by MicroCT show a more structured tissue around BMP2 samples. The present concept will give the best clinical results if both growth factors are delivered together by a coating film that contains a double population of microcarriers.

The Proteomic Signature of Intestinal Acute Rejection in the Mouse.

Intestinal acute rejection (AR) lacks a reliable non-invasive biomarker and AR surveillance is conducted through frequent endoscopic biopsies. Although citrulline and calprotectin have been suggested as AR biomarkers, these have limited clinical value. Using a mouse model of intestinal transplantation (ITx), we performed a proteome-wide analysis and investigated rejection-related proteome changes that may eventually be used as biomarkers. ITx was performed in allogenic (Balb/C to C57Bl) and syngeneic (C57Bl) combinations. Graft samples were obtained three and six days after transplantation (n = 4/time point) and quantitative proteomic analysis with iTRAQ-labeling and mass spectrometry of whole tissue homogenates was performed. Histology showed moderate AR in all allografts post-transplantation at day six. Nine hundred and thirty-eight proteins with at least three unique peptides were identified in the intestinal grafts. Eighty-six proteins varying by >20% between time points and/or groups had an alteration pattern unique to the rejecting allografts: thirty-seven proteins and enzymes (including S100-A8 and IDO-1) were significantly upregulated whereas forty-nine (among other chromogranin, ornithine aminotransferase, and arginase) were downregulated. Numerous proteins showed altered expression during intestinal AR, several of which were previously identified to be involved in acute rejection, although our results also identified previously unreported proteome changes. The metabolites and downstream metabolic pathways of some of these proteins and enzymes may become potential biomarkers for intestinal AR.

The Double Stitch Everting Technique in the End-to-Side Microvascular Anastomosis: Validation of the Technique Using a Randomized N-of-1 Trial.

BACKGROUND: The double stitch everting (DSE) technique, in which time is won by leaving the needle inside the vessel wall in-between stitching, is a modification of the end-to-side (ETS) anastomosis in the interest of reducing anastomosis time. This ensures proper wall eversion, intima-to-intima contact, and improved suture symmetry. METHODS: We designed an N-of-1 randomized trial with each microsurgeon as their own control. We included 10 microsurgeons of different levels of experience who were then asked to perform classic and DSE ETS anastomoses on the chicken leg and rat femoral models. Every anastomosis was cut and evaluated using blinded assessment. Two-way analysis of variance (ANOVA) and multivariable logistic regression were used to analyze the results and for confounder adjustment. RESULTS: A total of 210 anastomoses were performed, of which 177 on the chicken leg and 43 on the rat femoral artery and vein. From the 210 anastomoses, 111 were performed using the classic technique and 99 using the DSE technique. The mean anastomosis time was 28.8 ± 11.3 minutes in the classic group and 24.6 ± 12 minutes in the DSE group (p < 0.001, t-test). There was a significant reduction (p < 0.001, two-way ANOVA) in the number of mistakes when using the DSE technique (mean 5.5 ± 2.6) compared with those using the classic technique (mean 7.7 ± 3.4). CONCLUSION: The DSE technique for ETS anastomoses improves anastomoses times in experienced and moderately experienced microsurgeons while also improving or maintaining suture symmetry and lowering the number of mistakes.