Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial.

OBJECTIVE: To report open-label phase data from a recent randomized controlled trial (RCT), after previous data from that study showed improved penile length and erectile function among post-prostatectomy men treated with Restorex penile traction therapy (RxPTT). MATERIALS AND METHODS: An RCT (NCT05244486) was performed to evaluate RxPTT vs no treatment (Tx) for 5 months, which was followed by a 3-month open-label phase. Men were stratified based on as-treated data: Group 1 = No Tx; Group 2 = No Tx → Tx; Group 3 = Tx → No Tx; Group 4 = Tx. Assessments included stretched penile length and standardized (International Index of Erectile Function [IIEF]) and non-standardized questionnaires. RESULTS: A total of 82 men were enrolled (mean age 58.6 years) with 9-month data available in 45 of the men. Baseline characteristics were similar among the cohorts. Comparing Group 1 and Group 4 (respectively), notable differences included: IIEF Erectile Function domain (IIEF-EF) score (-8 vs -0.5; P = 0.16), penile length (-0.1 vs +1.7 cm; P < 0.01), intracavernosal injection use (86% vs 14%; P < 0.01), Sexual Encounter Profile (SEP) Question 2 (50% vs 100%; P < 0.01), SEP Question 3 (33% vs 100%; P < 0.01). Men who crossed over to Tx (Group 2) failed to achieve equivalent improvements in length (+0.5 cm) or sexual function (IIEF-EF score -6) compared to men treated early (Groups 3 and 4). Those who crossed over to no treatment after initial treatment (Group 3) experienced preserved length (+1.8 cm), and erectile function (IIEF-EF score +0) despite therapy discontinuation. CONCLUSIONS: Use of RxPTT beginning 1 month post-prostatectomy results in improved penile length and erectile function, with benefits maintained after discontinuing therapy. If confirmed, these results represent the first postoperative therapy shown in a RCT to improve erectile function post-prostatectomy. External validation is warranted.

Development of a single device to quantify motor impairments of the elbow: proof of concept.

BACKGROUND: For patients with post-stroke upper limb impairments, the currently available clinical measurement instruments are inadequate for reliable quantification of multiple impairments, such as muscle weakness, abnormal synergy, changes in elastic joint properties and spasticity. Robotic devices to date have successfully achieved precise and accurate quantification but are often limited to the measurement of one or two impairments. Our primary aim is to develop a robotic device that can effectively quantify four main motor impairments of the elbow. METHODS: The robotic device, Shoulder Elbow Perturbator, is a one-degree-of-freedom device that can simultaneously manipulate the elbow joint and support the (partial) weight of the human arm. Upper limb impairments of the elbow were quantified based on four experiments on the paretic arm in ten stroke patients (mean age 65 ± 10 yrs, 9 males, post-stroke) and the non-dominant arm in 20 healthy controls (mean age 65 ± 14 yrs, 6 males). The maximum strength of elbow flexor and elbow extensor muscles was measured isometrically at 90-degree elbow flexion. The maximal active extension angle of the elbow was measured under different arm weight support levels to assess abnormal synergy. Torque resistance was analyzed during a slow (6°/s) passive elbow rotation, where the elbow moved from the maximal flexion to maximal extension angle and back, to assess elastic joint properties. The torque profile was evaluated during fast (100°/s) passive extension rotation of the elbow to estimate spasticity. RESULTS: The ten chronic stroke patients successfully completed the measurement protocol. The results showed impairment values outside the 10th and 90th percentile reference intervals of healthy controls. Individual patient profiles were determined and illustrated in a radar figure, to support clinicians in developing targeted treatment plans. CONCLUSION: The Shoulder Elbow Perturbator can effectively quantify the four most important impairments of the elbow in stroke patients and distinguish impairment scores of patients from healthy controls. These results are promising for objective and complete quantification of motor impairments of the elbow and monitoring patient prognosis. Our newly developed Shoulder Elbow Perturbator can therefore in the future be employed to evaluate treatment effects by comparing pre- and post-treatment assessments.

Prognostic Impact of In-Hospital Use of Mechanical Cardiopulmonary Resuscitation Devices Compared with Manual Cardiopulmonary Resuscitation: A Nationwide Population-Based Observational Study in South Korea.

Background and Objectives: This study analyzed the prognostic impact of mechanical cardiopulmonary resuscitation (CPR) devices in out-of-hospital cardiac arrest (OHCA) patients, in comparison to manual CPR. Materials and Methods: This study was a nationwide population-based observational study in South Korea. Data were retrospectively collected from 142,905 OHCA patients using the South Korean Out-of-Hospital Cardiac Arrest Surveillance database. We included adult OHCA patients who received manual or mechanical CPR in the emergency room. The primary outcome was survival at discharge and the secondary outcome was sustained return of spontaneous circulation (ROSC). Statistical analysis included propensity score matching and multivariate logistic regression. Results: A total of 19,045 manual CPR and 1125 mechanical CPR cases (671 AutoPulseTM vs. 305 ThumperTM vs. 149 LUCASTM) were included. In the matched multivariate analyses, all mechanical CPR devices were associated with a lower ROSC than that of manual CPR. AutoPulseTM was associated with lower survival in the multivariate analysis after matching (aOR with 95% CI: 0.57 (0.33-0.96)), but the other mechanical CPR devices were associated with similar survival to discharge as that of manual CPR. Witnessed arrest was commonly associated with high ROSC, but the use of mechanical CPR devices and cardiac origin arrest were associated with low ROSC. Only target temperature management was the common predictor for high survival. Conclusions: The mechanical CPR devices largely led to similar survival to discharge as that of manual CPR in OHCA patients; however, the in-hospital use of the AutoPulseTM device for mechanical CPR may significantly lower survival compared to manual CPR.

Wet chemical development of CuO/GO nanocomposites: its augmented antimicrobial, antioxidant, and anticancerous activity.

This study employed a bottom-up technique to synthesize copper oxide (CuO) nanoparticles over hydrophilic graphene oxide (GO) nanosheets. The CuO/GO nanocomposite has been prepared using two selected precursors of copper nitrate and citric acid with an intermittent mixing of GO solutions. The synthesized Nanocomposites were characterized using different biophysical techniques like FT-IR, NMR, FE-SEM, and HR-TEM analyses. FT-IR analyses confirm the nanocomposites' successful formation, which is evident from the functional groups of C=C, C-O, and Cu-C stretching vibrations. Morphological analyses reveal the depositions of CuO nanoparticles over the planar rough GO sheets, which has been elucidated from the FE-SEM and HR-TEM analyses supported by respective EDAX analyses. The antimicrobial activities have been evident from the surface roughness and damages seen from the FE-SEM analyses. The CuO/GO sheets were tested against Gram-positive (e.g., Staphylococcus aureus) and Gram-negative (Escherichia coli, Pseudomonas aeruginosa). It is evident that the intrinsic antibacterial activity of CuO/GO sheets, when combined in equal proportions, elicited a robust antibacterial activity when tested over Gram -ve representative bacteria Escherichia coli. The antioxidant behaviour of synthesized CuO/GO nanocomposite was evaluated by scavenging the free radicals of DPPH and ABTS. Moreover, the cytotoxic activity was also studied against epidermoid carcinoma cell line A-431. A brief mathematical formulation has been proposed in this study to uncover the possibilities of using the nanocomposites as potential drug candidates in theranostic applications in disease treatment and diagnosis. This study would help uncover the electronic properties that play in the nano-scaled system at the material-bio interface, which would aid in designing a sensitive nano-electromechanical device bearing both the therapeutic and diagnostic attributes heralding a new horizon in the health care systems.

Robotics-inspired biology.

For centuries, designers and engineers have looked to biology for inspiration. Biologically inspired robots are just one example of the application of knowledge of the natural world to engineering problems. However, recent work by biologists and interdisciplinary teams have flipped this approach, using robots and physical models to set the course for experiments on biological systems and to generate new hypotheses for biological research. We call this approach robotics-inspired biology; it involves performing experiments on robotic systems aimed at the discovery of new biological phenomena or generation of new hypotheses about how organisms function that can then be tested on living organisms. This new and exciting direction has emerged from the extensive use of physical models by biologists and is already making significant advances in the areas of biomechanics, locomotion, neuromechanics and sensorimotor control. Here, we provide an introduction and overview of robotics-inspired biology, describe two case studies and suggest several directions for the future of this exciting new research area.

Bilateral upper limb rehabilitation with videogame-based feedback in corticobasal degeneration: a case reports study.

Corticobasal degeneration (CBD) is a neurodegenerative disorder characterized by a combination of cortical and basal ganglia signs. We reported two cases treated with a bilateral upper limb rehabilitation tool with videogame based feedback for 3 time per week for 8 weeks. Both patients showed an improvement of pinch and grasp forces and motor function. However, both of them reported an increased upper limb pain. Bilateral upper limb mechanical device with exergame feedback was effective also in the two patients suffering of CBD for limiting the effects of apraxia by performing intensive purposeful task training.

Sensoring a Generative System to Create User-Controlled Melodies.

The automatic generation of music is an emergent field of research that has attracted the attention of countless researchers. As a result, there is a broad spectrum of state of the art research in this field. Many systems have been designed to facilitate collaboration between humans and machines in the generation of valuable music. This research proposes an intelligent system that generates melodies under the supervision of a user, who guides the process through a mechanical device. The mechanical device is able to capture the movements of the user and translate them into a melody. The system is based on a Case-Based Reasoning (CBR) architecture, enabling it to learn from previous compositions and to improve its performance over time. The user uses a device that allows them to adapt the composition to their preferences by adjusting the pace of a melody to a specific context or generating more serious or acute notes. Additionally, the device can automatically resist some of the user's movements, this way the user learns how they can create a good melody. Several experiments were conducted to analyze the quality of the system and the melodies it generates. According to the users' validation, the proposed system can generate music that follows a concrete style. Most of them also believed that the partial control of the device was essential for the quality of the generated music.

A Mechatronic Loading Device to Stimulate Bone Growth via a Human Knee.

This paper presents the design of an innovative device that applies dynamic mechanical load to human knee joints. Dynamic loading is employed by applying cyclic and periodic force on a target area. The repeated force loading was considered to be an effective modality for repair and rehabilitation of long bones that are subject to ailments like fractures, osteoporosis, osteoarthritis, etc. The proposed device design builds on the knowledge gained in previous animal and mechanical studies. It employs a modified slider-crank linkage mechanism actuated by a brushless Direct Current (DC) motor and provides uniform and cyclic force. The functionality of the device was simulated in a software environment and the structural integrity was analyzed using a finite element method for the prototype construction. The device is controlled by a microcontroller that is programmed to provide the desired loading force at a predetermined frequency and for a specific duration. The device was successfully tested in various experiments for its usability and full functionality. The results reveal that the device works according to the requirements of force magnitude and operational frequency. This device is considered ready to be used for a clinical study to examine whether controlled knee-loading could be an effective regimen for treating the stated bone-related ailments.

A New Mechanical Mouth Opener for Dynamic Magnetic Resonance Imaging of the Temporomandibular Joint.

(1) Background: During the magnetic resonance imaging (MRI) of the temporomandibular joint (TMJ), it is necessary to scan the joints in the closed- and open-jaw position, as well as in the maximally open-jaw position. In order to examine both joints in these positions, an MRI compatible mouth opener is required, which allows the articular surfaces to maintain their position stably. (2) Methods: In this study, we included 200 patients aged 18 to 65, with various levels of clinical severity. The mouth opener is made of polymethyl methacrylate and used for dynamic imaging of TMJ. It is in the form of an arrow, with incisures on upper and lower surfaces 1 mm apart and these match possible variations in jaw opening. All the patients were scanned with mouth opener and, immediately after this scanning, with syringe (20 ccm) as a standard device used for mouth opening in clinical setting. (3) Results: A total of 200 MR examinations of TMJs were performed and the mechanical mouth opener was successfully applied without artifacts in all patients. The mouth opener device proved to be adequate in case of MRI of the TMJ for different ranges of mouth opening with the proper protocol for provoked imaging, because the incisures are located at a distance of 1 mm and no objective artifacts were observed in any examination that degraded the diagnostic quality of the examination. (4) Conclusions: The design of the acrylate mouth opener is precisely defined, and it has a purpose in the MRI diagnosis of TMJ disorders.

Bond strength between a veneering composite resin and zirconia frameworks with attached mechanical retentive devices.

The effects of mechanical retentive devices and various surface treatments on the shear bond strength between a veneering composite resin and zirconia was investigated. Zirconia disks were classified into three surface-treatment groups: airborne-particle abrasion, overglazing, and overglazing with white alumina particles of three different grain sizes (50, 70, and 105 µm) attached onto zirconia disks (ZR-50, ZR-70, and ZR-105, respectively). They were further divided into four groups (n=44): unprimed, Clearfil Porcelain Bond Activator (CA), Clearfil Photo Bond (CB), and CA+CB. An indirect composite resin was bonded to zirconia specimens. Shear bond strengths were measured. For the ZR-70 and ZR-105 groups, the CB and CA+CB specimens exhibited higher bond strengths than the other two specimens after thermocycling. The ZR-70 and ZR-105 groups achieved micromechanical interlocking, and priming with a phosphate monomer (MDP) yielded stable bond strengths between the composite resin and zirconia with alumina particles attached as retentive devices.

Technical note: Validity of a non-destructive device for opening dental arches in rigor mortis cadavers.

Forensic dental autopsy is a fundamental procedure for the study of a death under judicial investigation in the search for postmortem (PM) information that can be compared with the antemortem (AM) data available from the cadaver. One of the major difficulties in taking postmortem evidence is the opening of the mouth, limited in many cases by the phenomenon of cadaveric rigidity or rigor mortis. The aim of this study was to evaluate the effectiveness of a new device designed to facilitate the opening of the dental arches in rigor mortis corpses. For this purpose, a sample of 30 corpses (22 men and 8 women; mean age 42.18 years and 38.75 years) from the Institute of Legal Medicine of the city of Lima (Peru) was analyzed. A forensic odontologist designed and manufactured the apparatus and carried out the sample analysis process. The initial and maximum measurements of oral cavity opening were recorded and a paired Student's t-test was applied to observe the difference between these initial and maximum measurements obtained (p < 0.05). The results showed that the average oral opening obtained with the new appliance was 43.83 ± 3.62 mm, with an average initial opening of 6.49 ± 3.04 mm (p < 0.001). The efficacy was similar in men and women (maximum opening M: 51.70 mm - F: 53.00 mm). In 29 of the 30 carcasses studied (96.7%) an opening greater than 40 mm was obtained, the latter being a minimum measurement sufficient to access the oral cavity. The efficacy of this new instrument for oral autopsy purposes is highlighted, since it does not cause destruction of the soft tissues and allows the correct manipulation of the oral structures present.

Axisymmetric bare freestanding films of highly viscous liquids: Preparation and real-time investigation of capillary leveling.

HYPOTHESIS: Thin liquid films are important in many scientific fields. In particular, films with both the surface layers exposed to a different fluid phase, known as freestanding films, are relevant in the ambit of foams and emulsions. Hence, there is a great interest in developing novel techniques allowing to form large and stable freestanding liquid films and to follow their dynamics. EXPERIMENTS: We develop a novel opto-mechanical tool allowing to perform and study the preparation and the capillary leveling flow of axisymmetric bare freestanding liquid films. The tool is composed by a customized motorized iris diaphragm and by an innovative joint imaging setup combining digital holography and white light color interferometry that enables real-time measurement of film thickness over a large field of view. The dynamics of films made of a model Newtonian fluid, i.e., high-viscosity silicone oil, is studied. Direct numerical simulations and a hydrodynamic model based on the lubrication theory are used to support the experimental results. FINDINGS: Iris opening induces the formation of large circular freestanding films with a stepped profile. Once iris opening is stopped, the films undergo a capillary leveling flow tending to flatten their profile. The leveling flow follows the theoretical scaling given by Ilton et al. [1]. We prove through numerical simulations that an equi-biaxial extensional flow occurs at the film center. Furthermore, we observe the formation and dynamics of dimples in bare freestanding films for the first time.

An overview of robotic/mechanical devices for post-stroke thumb rehabilitation.

PURPOSE: This article aims to clarify the current state-of-the-art of robotic/mechanical devices for post-stroke thumb rehabilitation as well as the anatomical characteristics and motions of the thumb that are crucial for the development of any device that aims to support its motion. METHODS: A systematic literature search was conducted to identify robotic/mechanical devices for post-stroke thumb rehabilitation. Specific electronic databases and well-defined search terms and inclusion/exclusion criteria were used for such purpose. A reasoning model was devised to support the structured abstraction of relevant data from the literature of interest. RESULTS: Following the main search and after removing duplicated and other non-relevant studies, 68 articles (corresponding to 32 devices) were left for further examination. These articles were analyzed to extract data relative to (i) the motions assisted/permitted - either actively or passively - by the device per anatomical joint of the thumb and (ii) mechanical-related aspects (i.e., architecture, connections to thumb, other fingers supported, adjustability to different hand sizes, actuators - type, quantity, location, power transmission and motion trajectory). CONCLUSIONS: Most articles describe preliminary design and testing of prototypes, rather than the thorough evaluation of commercially ready devices. Defining appropriate kinematic models of the thumb upon which to design such devices still remains a challenging and unresolved task. Further research is needed before these devices can actually be implemented in clinical environments to serve their intended purpose of complementing the labour of therapists by facilitating intensive treatment with precise and repeatable exercises. Implications for Rehabilitation Post-stroke functional disability of the hand, and particularly of the thumb, significantly affects the capability to perform activities of daily living, threatening the independence and quality of life of the stroke survivors. The latest studies show that a high-dose intensive therapy (in terms of frequency, duration and intensity/effort) is the key to effectively modify neural organization and recover the motor skills that were lost after a stroke. Conventional therapy based on manual interaction with physical therapists makes the procedure labour intensive and increases the costs. Robotic/mechanical devices hold promise for complementing conventional post-stroke therapy. Specifically, these devices can provide reliable and accurate therapy for long periods of time without the associated fatigue. Also, they can be used as a means to assess patients? performance and progress in an objective and consistent manner. The full potential of robot-assisted therapy is still to be unveiled. Further exploration will surely lead to devices that can be well accepted equally by therapists and patients and that can be useful both in clinical and home-based rehabilitation practice such that motor recovery of the hand becomes a common outcome in stroke survivors. This overview provides the reader, possibly a designer of such a device, with a complete overview of the state-of-the-art of robotic/mechanical devices consisting of or including features for the rehabilitation of the thumb. Also, we clarify the anatomical characteristics and motions of the thumb that are crucial for the development of any device that aims to support its motion. Hopefully, this?combined with the outlined opportunities for further research?leads to the improvement of current devices and the development of new technology and knowledge in the field.

Wet milling of large quantities of human excision adipose tissue for the isolation of stromal vascular fraction cells.

The isolation of stromal vascular fraction (SVF) cells from excised human adipose tissue, for clinical or research purposes, implies the tedious and time consuming process of manual mincing prior to enzymatic digestion. Since no efficient alternative technique to this current standard procedure has been proposed so far, the aim of this study was to test a milling procedure, using two simple, inexpensive and commercially available manual meat grinders, to process large amounts of adipose tissue. The procedure was assessed on adipose tissue resections from seven human donors and compared to manual mincing with scalpels. The processed adipose tissues were digested and the resulting SVF cells compared in terms of number, clonogenicity and differentiation capacity. After 10 min of processing, either device tested yielded on average sixfold more processed material for subsequent cell isolation than manual mincing. The isolation yield of SVF cells (isolated cells per ml of adipose tissue), their viability, phenotype, clonogenicity and osteogenic/adipogenic differentiation capacity, tested by production of mineralized matrix and lipid vacuoles, respectively, were comparable. This new method is practical and inexpensive and represents an efficient alternative to the current standard for large scale adipose tissue resection processing. A device based on the milling principle could be embedded within a streamlined system for isolation and clinical use of SVF cells from adipose tissue excision.

Design and evaluation of an actuated knee implant for postoperative ligament imbalance correction.

In Total Knee Arthroplasty (TKA), the collateral ligament tensioning stage cannot be standardised for all patients and relies heavily on the surgeon's experience and perception. Intraoperative inaccuracies are practically unavoidable and may give rise to severe postoperative complications, leading to the need for revision surgery already a few years after primary TKA. This work proposes a novel instrumented tibial component able to detect collateral ligament laxity conditions right after primary TKA and, if needed, to compensate for them in the postoperative period. A miniaturised actuation system, designed to be embedded in the tibial baseplate, was initially evaluated by means of 3D simulations and then fabricated as a full-scale prototype. Stability and force sensors tests carried out on a knee simulator allowed to assess the effectiveness of the proposed design under normal working conditions and provided valuable insights for future work and improvements.

Microanastomosis venosa mecánica coupler®: un importante aporte tecnológico a la microcirugía vascular / Coupler® venous mechanic microanastomosis: an important technological contribution to microvascular surgery

Objetivo: El objetivo del presente trabajo es dar a conocer la experiencia de nuestro grupo de Cirugía Plástica, en sutura mecánica microvascular utilizando el dispositivo Coupler® (Synovis Corp, Birmingham, AL) para las anastomosis venosas realizadas en pacientes sometidos microcirugía reconstructiva. Material y Método: Revisión retrospectiva de los últimos 48 colgajos libres operados entre marzo de 2009 y febrero de 2013. Todas las anastomosis microquirúrgicas venosas fueron realizadas con el dispositivo Coupler® y las anastomosis arteriales con sutura separada o continua de nylon 9-0 ó 10-0. Los datos recolectados fueron: datos personales y médicos del paciente, localización del defecto, colgajo utilizado, diámetro de los vasos, anastomosis arterial, Coupler® utilizado, tiempo de anastomosis, complicaciones postoperatorias, trombosis arterial y trombosis venosa. Resultados: Fueron realizados 48 colgajos libres para reconstrucción de extremidad inferior (n = 25, 52,1 por ciento); cabeza-cuello (n = 15, 31 por ciento); mama (n = 5, 10,4 por ciento) y extremidad superior (n = 3, 6,3 por ciento). Los colgajos utilizados fueron: Anterolateral de muslo o ALT (n = 25, 52,1 por ciento), Radial (n = 10, 20,8 por ciento), Perforante de Arteria Epigástrica Inferior o DIEP (n = 5, 10,4 por ciento), Dorsal Ancho (n = 2, 4,2 por ciento), Recto Abdominal (n = 2, 4,2 por ciento), Fíbula (n = 2, 4,2 por ciento), Escápula (n = 1, 2,1), y Gracilis (n = 1, 2,1 por ciento). El diámetro promedio del dispositivo Coupler® utilizado en el total de los casos fue de 2,51 +/- 0,46 mm. El tiempo promedio para la anastomosis venosa fue de 13,5 +/- 7,3 min. Un total de 4 colgajos se perdieron (8,3 por ciento), ninguno a causa de falla venosa. Conclusiones: El Coupler® venoso es un elemento seguro, efectivo y rápido para la realización de las anastomosis microquirúrgicas, es fácil de aprender y su implementación debiese ser considerada en todo centro donde se realice microcirugía.

Aim: The aim of the present paper is to show the experience of the Plastic Surgery Division at the University of Chile Clinical Hospital, with the Coupler® anastomotic device (Synovis Corp, Birmingham, AL) for venous microanastomoses in patients undergoing reconstructive microsurgery. Material and Methods: A retrospective review of 48 consecutive patients with free flaps between March 2009 and in February 2013. All microsurgical venous anastomoses were performed with the Coupler® device and the arterial anastomoses with interrupted or continuous 9-0 or 10-0 nylon sutures. The collected data were: personal and medical patient information, location of the defect, flap used, vessels diameter, arterial anastomoses, Coupler® used, time of anastomosis, postoperative complications, arterial and venous thrombosis. Results: A total of 48 free flaps were performed for reconstruction of lower extremity (n = 25, 52.1%); head-neck (n = 15, 31%); breast (n = 5, 10.4%) and upper extremity (n = 3, 6.3%). The flaps used were: Anterolateral thigh or ALT (n = 25, 52.1%), Radial (n = 10, 20.8%), Deep Inferior Epigastric Artery Perforator or DIEP (n = 5, 10.4%), Latisimus Dorsi (n = 2, 4.2%), Rectus Abdominus (n = 2, 4.2%), Fibula (n = 2, 4.2%), Scapula (n = 1, 2.1%), and Gracilis (n = 1, 2.1%). The Coupler device average diameter used was 2.51 ± 0.46 mm. The average time for the venous anastomosis was 13.5 ± 7.3 minutes. A total of 4 flaps were lost (8.3%), none due to venous thrombosis. Conclusions: The Coupler® System for venous anastomoses is a safe, effective and quick method for microsurgical anastomoses, it is easy to learn and its implementation should be considered in every microvascular surgery center.

Aplicabilidad de un nuevo dispositivo mecánico para hibrid disección submucosal endoscópica en modelos experimentales exvivo / Applicability of a new mechanical device for ebdiscopic sub mucosal hybrid dissection in live experimental models

La disección submucosal endoscópica es una técnica terapéutica prometedora para la resección en bloque de tumores gastrointestinales. Esta técnica tiene sus desventajas, tiempo de intervención largo, complejidad del procedimiento, y tasa de complicaciones. Mostrar la aplicabilidad y seguridad de la Hibrid disección submucosal endoscópica en estómago de cerdos exvivos utilizando dispositivo mecánico para elevar la pieza a disecar. 4 endoscopistas expertos en Hibrid disección submucosal endoscópica en modelos experimentales ex vivos realizaron disección submucosal endoscópica utilizando la técnica Hibrid Knife y dispositivo mecánico por fuera del canal de trabajo para elevar la pieza a disecar. Tiempo de intervención y tasa de complicaciones durante la introducción del dispositivo y la disección submucosal endoscópica (DSE) fue documentada. 11 procedimientos fueron realizados. En los primeros 4 procedimientos, el tiempo promedio de DSE fue 6.5 min (lesiones < 2cms), en los siguientes 4 procedimientos 9.5 min (lesiones entre 2- 3 cms) y en los 3 últimos procedimientos 10.33 min (lesiones > 3 cms). No hubo complicaciones. En nuestro trabajo el uso del dispositivo mecánico pareciera facilitar la técnica Hibrid-DSE haciéndola menos laboriosa, disminuyendo el tiempo y la tasa de complicaciones, se necesitaran estudios in vivo

The endoscopic submucosal dissection is a promising therapeutic technique for bloc resection of gastrointestinal tumors. However, this technique has some disadvantages like long intervention time, complexity of procedure and complications rate. To show the applicability and security of the endoscopic submucosal hybrid dissection in pigs stomach alive, using a mechanical device to lift up the piece to be dissected. 4 endoscopic submucosal hybrid dissection expert physicians, in live experimental models performed the submucosal endoscopic dissection using the Hybrid Knife technique and the mechanical device out of the working channel, in order to lift up the piece to be dissected.The intervention time and difficulty rate during the device introduction and the ESD (Endoscopic Sub mucosal Dissection) were documented. A total of 11 procedures were performed. In the first 4 procedures, the average time of DSE was 6.5 min (lesions < 2cms), in the following 4 procedures 9.5 min (lesions between 2 to 3 cm) and in the last 3 procedures was 10.33 min (lesions > 3 cm). There were no complications. In our work, to use the mechanical device seems to ease the Hybrid ESD, making it less difficult, diminishing time and complication rates. Live study will be necessary