RESUMEN
INTRODUCTION: Intraoperative blood loss and postoperative hemorrhage affect outcomes after liver resection. GATT-Patch is a new flexible, pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with N-hydroxy-succinimide polyoxazoline. We evaluated safety and performance of the GATT-Patch for hemostasis at the liver resection plane. METHODS: Adult patients undergoing elective open liver surgery were recruited in three centers. GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated bleeding site at 3 min versus a prespecified performance goal of 65.4%. RESULTS: Two trial stages were performed: I (n = 8) for initial safety and II (n = 39) as the primary outcome cohort. GATT-Patch was applied in 47 patients on 63 bleeding sites. Median age was 60.0 (range 25-80) years and 70% were male. Most (66%) surgeries were for colorectal cancer metastases. The primary endpoint was met in 38 out of 39 patients (97.4%; 95% confidence interval: 84.6%-99.9%) versus 65.4% (P < 0.001). Of all the 63 bleeding sites, hemostasis was 82.7% at 30, 93.7% at 60, and 96.8% at 180 s. No reoperations for rebleeding or device-related issues occurred. CONCLUSIONS: When compared to a performance goal derived from state-of-the-art hemostatic agents, GATT-Patch for the treatment of minimal to moderate bleeding during liver surgery successfully and quickly achieved hemostasis with acceptable safety outcomes. (ClinicalTrials.gov Identifier: NCT04819945).
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Pérdida de Sangre Quirúrgica , Hepatectomía , Humanos , Masculino , Persona de Mediana Edad , Femenino , Anciano , Adulto , Hepatectomía/efectos adversos , Hepatectomía/métodos , Anciano de 80 o más Años , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Pérdida de Sangre Quirúrgica/prevención & control , Hemostasis Quirúrgica/métodos , Hemostasis Quirúrgica/instrumentación , Hemostáticos/administración & dosificación , Hemostáticos/uso terapéutico , Hemostáticos/efectos adversos , Resultado del Tratamiento , Gelatina/efectos adversos , Gelatina/administración & dosificación , Estudios Prospectivos , Neoplasias Hepáticas/cirugía , Neoplasias Hepáticas/secundarioRESUMEN
Objective. CoolSeal is a new vessel sealing system for dissection and hemostasis during surgery. No clinical studies have investigated safety, advantages or disadvantages regarding the use of this device. The aim of the present study was to investigate the safety of CoolSeal and compare it with conventional ligation technique or LigaSure during the total thyroidectomy. We hypothesized that the use of CoolSeal would reduce the operating time and bleeding without complications increase. Study design represents a retrospective cohort study with a tertiary reference center setting. Methods. We analyzed total thyroidectomy data from January 2021 to June 2023. We recorded patients' characteristics, surgical information, and postoperative outcome. Results. We performed 221 total thyroidectomies in the study period. Analysis was restricted to 171 patients operated by only two surgeons. Hemostasis was secured by conventional ligation in 117 patients (68%), LigaSure in 34 patients (20%) and CoolSeal in 20 patients (12%). Median thyroid weight and bleeding were 67 g and 50 ml, respectively. Procedures using LigaSure or Cool-Seal were on larger glands (median 205 g) without increased bleeding (50 ml). Operating time was shortest with CoolSeal (96 min, p=0.003) compared with LigaSure (117 min) or conventional ligation (115 min). Bleeding was reduced with CoolSeal compared with LigaSure (45 vs. 100 ml, p=0.003). With CoolSeal, median hospitalization was one postoperative day, no patients required re-operation. There was no palsy of recurrent laryngeal nerves and no permanent hypoparathyroidism. Conclusion. In our first clinical experience, CoolSeal was safe and efficient for total thyroidectomy. With a small sample size, we saw a clinical benefit with reduced operating time without post-operative complications increase.
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Pérdida de Sangre Quirúrgica , Hemostasis Quirúrgica , Tempo Operativo , Tiroidectomía , Humanos , Tiroidectomía/métodos , Tiroidectomía/instrumentación , Tiroidectomía/efectos adversos , Femenino , Masculino , Estudios Retrospectivos , Persona de Mediana Edad , Adulto , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Pérdida de Sangre Quirúrgica/prevención & control , Anciano , Ligadura/instrumentación , Ligadura/métodos , Resultado del TratamientoRESUMEN
The Hem-o-lok Weck clip is part of a polymer locking ligation system often employed for hemostasis in surgical practices. Its use is routine in a wide array of surgical subspecialties. Surgeons have limited options in removing these clips when they are aberrantly positioned. Herein, we describe a novel, cost-effective approach for removing a Hem-o-lok clip using standard robotic instruments. This simple approach will allow surgeons to remove a Hem-o-lok clip precisely and quickly if it is not adequately placed. During a routine robotic-assisted laparoscopic prostatectomy a Hem-o-lok Weck clip was noted to be in juxtaposition to the rectal wall, and it was deemed appropriate to remove it. Ultimately, the indwelling Prograsp forceps was moved from the right fourth arm position to the left arm position. This allowed the Prograsp forceps to compress the scissors in the right hand port, which was insufficient in cutting the hinge of the clip. This provided sufficient force to cut through the clip at its hinge with ease. The Hem-o-lok Weck clip is used in various surgical specialties. It is occasionally placed suboptimally and requires removal. Given the challenge of finding and using the clip removal device, surgeons should be aware of this simple and cost-effective way of removing a Hem-o-lok clip if desired.
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Análisis Costo-Beneficio , Prostatectomía , Procedimientos Quirúrgicos Robotizados , Instrumentos Quirúrgicos , Humanos , Masculino , Instrumentos Quirúrgicos/economía , Prostatectomía/métodos , Prostatectomía/economía , Prostatectomía/instrumentación , Procedimientos Quirúrgicos Robotizados/economía , Procedimientos Quirúrgicos Robotizados/instrumentación , Remoción de Dispositivos/métodos , Remoción de Dispositivos/economía , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/economía , Hemostasis Quirúrgica/métodos , Laparoscopía/economía , Laparoscopía/métodos , Pérdida de Sangre Quirúrgica/prevención & controlRESUMEN
BACKGROUND: Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). METHODS: This randomized controlled trial evaluates the exsanguination tourniquet ring's effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. RESULTS: The experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device. CONCLUSIONS: The exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries. TRIAL REGISTRATION: Comparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.
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Pérdida de Sangre Quirúrgica , Exsanguinación , Torniquetes , Humanos , Femenino , Masculino , Persona de Mediana Edad , Pérdida de Sangre Quirúrgica/prevención & control , Torniquetes/efectos adversos , Adulto , Exsanguinación/etiología , Extremidades/cirugía , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Anciano , Resultado del Tratamiento , Estudios ProspectivosRESUMEN
Electrosurgical and ultrasonic devices are used in surgical procedures for hemostatic sealing and bisection of vascular tissues. Previous benchtop studies alternatively demonstrated successful infrared laser sealing and cutting of blood vessels, in a sequential, two-step approach. This study describes a smaller, laparoscopic device compatible design, and simultaneous approach to sealing and bisection of vessels, with potential optical feedback. A 1470-nm infrared diode laser sealed and bisected 40 porcine renal arteries, ex vivo. A reciprocating, side-firing, optical fiber, housed in a transparent square quartz optical chamber (2.7 × 2.7 × 25 mm outer dimensions), delivered laser energy over an 11 mm scan length, with a range of incident powers (41-59 W) and treatment times (5-21 s). Vessel diameters ranged from 2.5 to 4.8 mm. Vessel burst pressure measurements were performed on each cut end (n = 80) with success indicated by pressures exceeding 360 mmHg. All vessel ends were successfully sealed and bisected (80/80). The highest incident power, 59 W, yielded short treatment times of 5-6 s. Peak temperatures on the external chamber surface reached 103 oC. Time to cool down to body temperature measured 37 s. Infrared lasers simultaneously seal and bisect blood vessels, with treatment times comparable to, and temperatures and cooling times lower than reported for conventional devices. Future work will focus on integrating the fiber and chamber into a standard 5-mm-outer-diameter laparoscopic device. Customization of fiber scan length to match vessel size may also reduce laser energy deposition, enabling lower peak temperatures, treatment times, and cooling times.
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Láseres de Semiconductores , Arteria Renal , Animales , Láseres de Semiconductores/uso terapéutico , Porcinos , Arteria Renal/cirugía , Rayos Infrarrojos , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Terapia por Láser/instrumentación , Terapia por Láser/métodos , Laparoscopía/métodos , Laparoscopía/instrumentaciónRESUMEN
BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery. METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. DISCUSSION: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .
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Equipos Desechables , Humanos , Estudios Prospectivos , Procedimientos Quirúrgicos Ultrasónicos/instrumentación , Procedimientos Quirúrgicos Ultrasónicos/métodos , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Masculino , Femenino , Pérdida de Sangre Quirúrgica/prevención & control , Adulto , Esófago/cirugía , Estudios Multicéntricos como Asunto , Resultado del Tratamiento , Estudios de Equivalencia como Asunto , Persona de Mediana Edad , Procedimientos Quirúrgicos Torácicos/métodos , Procedimientos Quirúrgicos Torácicos/instrumentaciónRESUMEN
OBJECTIVE: This study aimed to describe a novel surgical technique for the management of antenatally suspected placenta accreta spectrum (PAS). STUDY DESIGN: This is a retrospective, case series of patients with suspected PAS undergoing peripartum hysterectomy with a reloadable articulating stapler at a tertiary care center. RESULTS: Eighteen patients with antenatally suspected PAS were identified and underwent peripartum hysterectomy with the aid of a reloadable stapler. Mean gestational age at delivery was 344/7 ± 11/7 weeks. Mean total operative time (skin-to-skin) was 117.3 ± 39.3 minutes, and 79.8 ± 19.8 minutes for the hysterectomy. Mean blood loss for the entire case was 1,809 ± 868 mL. Mean blood loss for the hysterectomy was 431 ± 421 mL. Mean units of intraoperative red blood cells transfused was 3 ± 1 units. Mean units of postoperative red blood cells transfused was 1 ± 0.5 units. Five cases were complicated by urological injury (two intentional cystotomies). Four patients were admitted to the intensive care unit (ICU) for a mean of ≤24 hours. Mean postoperative LOS was 4.11 ± 1.45 days. Three patients had final pathology that did not demonstrate PAS while four were consistent with accreta, six increta, and five percreta. CONCLUSION: Use of a reloadable articulating stapler device as part of the surgical management of antenatally suspected PAS results in a shorter operative time (117 ± 39 minutes vs. 140-254 minutes previously reported), lower average blood loss (1,809 ± 868 mL vs. 2,500-5,000 mL previously reported) and shorter LOS (4.11 ± 1.45 days vs. 9.8 ± 13.5 days previously reported) compared with traditional cesarean hysterectomy. The reloadable stapling device offers an advantage of more rapidly achieving hemostasis in the surgical management of PAS. KEY POINTS: · PAS is associated with severe maternal morbidity.. · Decreased operative time and blood loss have many clinical benefits.. · Reloadable stapler use for PAS decreases operative time.. · Reloadable stapler use for PAS decreases operative blood loss..
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Cesárea/instrumentación , Hemostasis Quirúrgica/instrumentación , Histerectomía/instrumentación , Placenta Accreta/cirugía , Engrapadoras Quirúrgicas , Adulto , Pérdida de Sangre Quirúrgica/prevención & control , Cesárea/métodos , Diseño de Equipo , Femenino , Hemostasis Quirúrgica/métodos , Humanos , Tempo Operativo , Periodo Periparto , Embarazo , Estudios RetrospectivosRESUMEN
BACKGROUND: Which type of closure after carotid endarterectomy (CEA), whether primary, patching, or eversion, will provide the optimal results has remained controversial. In the present study, we compared the results of randomized controlled trials (RCTs) and systematic meta-analyses of the various types of closure. METHODS: We conducted a PubMed literature review search to find studies that had compared CEA with primary closure, CEA with patching, and/or eversion CEA (ECEA) during the previous three decades with an emphasis on RCTs, previously reported systematic meta-analyses, large multicenter observational studies (Vascular Quality Initiative data), and recent single-center large studies. RESULTS: The results from RCTs comparing primary patching vs primary closure were as follows. Most of the randomized trials showed CEA with patching was superior to CEA with primary closure in lowering the perioperative stroke rates, stroke and death rates, carotid thrombosis rates, and late restenosis rates. These studies also showed no significant differences between the preferential use of several patch materials, including synthetic patches (polyethylene terephthalate [Dacron; DuPont, Wilmington, Del], Acuseal [Gore Medical, Flagstaff, Ariz], polytetrafluoroethylene, or pericardial patches) and vein patches (saphenous or jugular). The results from observational studies comparing patching vs primary closure were as follows. The Vascular Study Group of New England data showed that the use of patching increased from 71% to 91% (P < .001). Also, the 1-year restenosis and occlusion (P < .01) and 1-year stroke and transient ischemic attack (P < .03) rates were significantly lower statistically with patch closure. The results from the RCTs comparing ECEA vs conventional CEA (CCEA) were as follows. Several RCTs that had compared ECEA with CCEA showed equivalency of CCEA vs ECEA (level 1 evidence) with patching in the perioperative carotid thrombosis and stroke rates. At 4 years after treatment, the incidence of carotid stenosis was lower for ECEA than for primary closure (3.6% vs 9.2%; P = .01) but was comparable between patching and eversion (1.5% for patching vs 2.8% for eversion). CONCLUSIONS: Routine carotid patching or ECEA was superior to primary closure (level 1 evidence). We found no significant differences between the preferential use of several patch materials. The rates of significant post-CEA stenosis for CEA with patching was similar to that with ECEA, and both were superior to primary closure.
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Enfermedades de las Arterias Carótidas/cirugía , Endarterectomía Carotidea , Hemostasis Quirúrgica , Enfermedades de las Arterias Carótidas/diagnóstico por imagen , Enfermedades de las Arterias Carótidas/mortalidad , Endarterectomía Carotidea/efectos adversos , Endarterectomía Carotidea/mortalidad , Hemostasis Quirúrgica/efectos adversos , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/mortalidad , Humanos , Complicaciones Posoperatorias/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Hematoma after thyroid surgery is a serious complication. The purpose of this study was to determine the predictors and consequences of hematoma after thyroid surgery. MATERIALS AND METHODS: A retrospective analysis of 11,552 open thyroidectomies was conducted using the American College of Surgeons National Surgical Quality Improvement Program 2016-2017 main and thyroidectomy-targeted procedure databases. Predictors of hematoma and the effect of hematoma on outcomes were analyzed by multivariate logistic regression, resulting in risk-adjusted odds ratios of hematoma and morbidity/mortality, respectively. Statistical analysis was performed using R version 3.5.1. RESULTS: We found that male gender (odds ratio 1.71, 95% confidence interval 1.25-2.32; P value 0.0007), Black race (1.89, 1.27-2.77; 0.0014), other race (1.76, 1.23-2.50; 0.0017), hypertension (1.68, 1.20-2.35; 0.0026), diabetes (1.45, 1.00-2.06; 0.0460), and bleeding disorders (3.63, 1.61-7.28; 0.0007) were independent risk factors for postoperative hematoma. The use of an energy device for hemostasis (0.63, 0.46-0.87; 0.0041) was independently associated with decreased hematoma rate. Postoperative hematoma was an independent risk factor for overall morbidity (3.04, 2.21-4.15; <0.0001), hypocalcemia (1.73, 1.08-2.66, 0.0162), recurrent laryngeal nerve injury (2.42, 1.57-3.60, <0.0001), pulmonary morbidity (18.91, 10.13-34.16, <0.0001), wound morbidity (10.61, 5.54-19.02, <0.0001), readmission (5.23, 3.34-7.92, <0.0001), return to operating room (90.73, 62.62-131.97; <0.0001), and length of stay greater than the median (5.10, 3.62-7.15, <0.0001). CONCLUSIONS: Identified by this study are the predictors of postthyroidectomy hematoma and the consequences thereof. Notably, the use of energy devices for hemostasis was shown to be protective of postoperative hematoma. The results of this study may guide pre- and intra-operative decision-making for thyroidectomy to reduce rates of postoperative hematoma.
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Hematoma/etiología , Complicaciones Posoperatorias/etiología , Tiroidectomía , Adulto , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Femenino , Hematoma/epidemiología , Hematoma/prevención & control , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Evaluación de Resultado en la Atención de Salud , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Factores Protectores , Estudios Retrospectivos , Ajuste de Riesgo , Factores de Riesgo , Estados UnidosRESUMEN
BACKGROUND: Extra peritoneal packing (EPP) is a quick and highly effective method to control pelvic hemorrhage. OBJECTIVES: To determine whether EPP can be as safely and efficiently performed in the emergency department (ED) as in the operating room (OR). METHODS: Retrospective study of 29 patients who underwent EPP in the ED or OR in two trauma centers in Israel 2008-2018. RESULTS: Our study included 29 patients, 13 in the ED-EPP group and 16 in the OR-EPP group. The mean injury severity score (ISS) was 34.9 ± 11.8. Following EPP, hemodynamic stability was successfully achieved in 25 of 29 patients (86.2%). A raise in the mean arterial pressure (MAP) with a median of 25 mmHg (mean 30.0 ± 27.5, P < 0.001) was documented. All patients who did not achieve hemodynamic stability after EPP had multiple sources of bleeding or fatal head injury and eventually succumbed. Patients who underwent EPP in the ED showed higher change in MAP (P = 0.0458). The overall mortality rate was 27.5% (8/29) with no difference between the OR and ED-EPP. No differences were found between ED and OR-EPP in the amount of transfused blood products, surgical site infections, and length of stay in the hospital. However, patients who underwent ED-EPP were more prone to develop deep vein thrombosis (DVT): 50% (5/10) vs. 9% (1/11) in ED and OR-EPP groups respectively (P = 0.038). CONCLUSIONS: EPP is equally effective when performed in the ED or OR with similar surgical site infection rates but higher incidence of DVT.
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Exsanguinación , Fracturas Óseas , Hemostasis Quirúrgica , Pelvis , Complicaciones Posoperatorias , Infección de la Herida Quirúrgica , Trombosis de la Vena , Determinación de la Presión Sanguínea/métodos , Servicio de Urgencia en Hospital/estadística & datos numéricos , Exsanguinación/diagnóstico , Exsanguinación/etiología , Exsanguinación/mortalidad , Exsanguinación/cirugía , Femenino , Fracturas Óseas/complicaciones , Fracturas Óseas/diagnóstico , Fracturas Óseas/cirugía , Hemostasis Quirúrgica/efectos adversos , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Humanos , Puntaje de Gravedad del Traumatismo , Israel/epidemiología , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Pelvis/diagnóstico por imagen , Pelvis/lesiones , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Infección de la Herida Quirúrgica/diagnóstico , Infección de la Herida Quirúrgica/etiología , Centros Traumatológicos/estadística & datos numéricos , Trombosis de la Vena/diagnóstico , Trombosis de la Vena/etiologíaRESUMEN
BACKGROUND & AIMS: It is not clear whether closure of mucosal defects with clips after colonic endoscopic mucosal resection (EMR) prevents delayed bleeding, although it seems to have no protective effects when risk is low. We performed a randomized trial to evaluate the efficacy of complete clip closure of large (≥2 cm) nonpedunculated colorectal lesions after EMR in patients with an estimated average or high risk of delayed bleeding. METHODS: We performed a single-blind trial at 11 hospitals in Spain from May 2016 through June 2018, including 235 consecutive patients who underwent EMR for large nonpedunculated colorectal lesions with an average or high risk of delayed bleeding (based on Spanish Endoscopy Society Endoscopic Resection Group score). Participants were randomly assigned to groups that received closure of the scar with 11-mm through-the-scope clips (treated, n = 119) or no clip (control, n = 116). The primary outcome was proportion of patients in each group with delayed bleeding, defined as evident hematochezia that required medical intervention within 15 days after colonoscopy. RESULTS: In the clip group, complete closure was achieved in 68 (57%) cases, with partial closure in 33 (28%) cases and failure to close in 18 (15%) cases. Delayed bleeding occurred in 14 (12.1%) patients in the control group and in 6 (5%) patients in the clip group (absolute risk difference, reduction of 7% in the clip group; 95% confidence interval, -14.7% to 0.3%). After completion of the clip closure, there was only 1 (1.5%) case of delayed bleeding (absolute risk difference, reduction of 10.6%; 95% confidence interval, -4.3% to 17.9%). CONCLUSIONS: In a randomized trial of patients with large nonpedunculated colorectal lesions undergoing EMR, we found that clip closure of mucosal defects in patients with a risk of bleeding can be a challenge, but also reduces delayed bleeding. Prevention of delayed bleeding required complete clip closure. ClinicalTrials.gov ID: NCT02765022.
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Adenocarcinoma/cirugía , Pólipos Adenomatosos/cirugía , Pólipos del Colon/cirugía , Neoplasias Colorrectales/cirugía , Resección Endoscópica de la Mucosa/efectos adversos , Hemorragia Gastrointestinal/prevención & control , Hemostasis Quirúrgica/instrumentación , Hemorragia Posoperatoria/prevención & control , Instrumentos Quirúrgicos , Adenocarcinoma/patología , Pólipos Adenomatosos/patología , Anciano , Anciano de 80 o más Años , Pólipos del Colon/patología , Neoplasias Colorrectales/patología , Diseño de Equipo , Femenino , Hemorragia Gastrointestinal/etiología , Humanos , Masculino , Persona de Mediana Edad , Hemorragia Posoperatoria/etiología , Medición de Riesgo , Factores de Riesgo , Método Simple Ciego , España , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: In equine abdominal surgery, resection and anastomosis of strangulated intestine is a commonly performed procedure. To date, ligatures, vessel sealing devices and the ligate-divide stapler have been described for this use in horses. The objective of this study was to compare the application of haemostatic clips and ligatures to occlude equine mesenteric vessels. Portions of jejunum with ten associated mesenteric vessels were collected from 12 horses at a local abattoir and divided into two groups. Portions of intestine were divided into two sections comprising five vessels each and assigned to Group A or Group B. Each vessel was occluded with a triple ligature. In Group A, vessels were ligated with three circumferential ligatures tied with a sliding knot with two overthrows. In Group B, vessels were occluded with application of three haemoclips. The procedures were performed by the same experienced surgeon. Intestinal length, construction time and vessel leaking pressure were measured and compared between groups. RESULTS: The intestinal length (mean ± SD) was 3.78 ± 0.43 m in Group A and 3.04 ± 0.83 m in Group B. The difference was not significant (p = 0.297). The construction time (mean ± SD) was 7.03 ± 0.34 min in Group A and 2.40 ± 0.43 min in Group B. The difference was significant (p < 0.0001). The leaking pressure was 1000 (750-1050) mmHg (median, IQ range) in Group A and 1050 (800-1050) mmHg (median, IQ range) in Group B. The difference was not significant (p = 0.225). CONCLUSIONS: Haemoclip application is comparable in terms of leaking pressure but quicker than sliding knots to apply.
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Hemostasis Quirúrgica/veterinaria , Caballos/cirugía , Yeyuno/cirugía , Animales , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Ligadura/métodos , Ligadura/veterinaria , Arterias Mesentéricas/cirugía , Venas Mesentéricas/cirugía , PresiónRESUMEN
Hemostatic devices used in the transradial approach (TRA) and transulnar approach (TUA) are limited. This study compared the efficacy and safety of hemostasis using the QuikClot Radial hemostatic pad (QC) vs. standard mechanical compression (SC) after coronary angiography (CAG). This prospective single-center randomized trial included CAG patients. The primary and secondary endpoints were efficacy (successful hemostasis) and safety (total artery occlusion [TAO], pseudoaneurysm, hematoma), respectively. A visual analog scale (VAS) evaluated patient pain during compression. In 2013-2017, 200 patients were randomized 2 × 2 into the: (1) TRA and TUA groups and (2) QC and SC groups. Successful hemostasis was achieved in 92 (92%) patients in the QC group and 100 (100%) patients in the SC group (p < 0.006). The TRA SC subgroup showed significantly better results than the TRA QC subgroup (100% vs. 90.0%; p < 0.03). Similar results were obtained in the TUA QC and TUA SC subgroups (95% vs. 100%; p = 0.5). The secondary endpoint was achieved in the QC and SC groups (8% vs. 9%; p = 0.8). Patients reported significantly less pain during QC application than during SC (VAS: 2.6 ± 2.6 vs. 3.4 ± 2.9; p < 0.03). In patients undergoing CAG with TRA or TUA, QC was associated with lower efficacy, less discomfort, and similar safety compared to SC.
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Cateterismo Periférico/efectos adversos , Vendajes de Compresión , Hemostasis Quirúrgica/instrumentación , Hemostasis Quirúrgica/métodos , Caolín/uso terapéutico , Arteria Radial/cirugía , Anciano , Cateterismo Periférico/métodos , Angiografía Coronaria/métodos , Femenino , Hemostáticos/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico , Evaluación de Procesos y Resultados en Atención de Salud , Intervención Coronaria Percutánea , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Mohs micrographic surgery, excisional surgery, and electrodessication and curettage (ED&C) are common dermatologic procedures that often use electrodessication through hyfrecators to achieve hemostasis. According to in vitro studies, electrodessication is considered safe in patients with implanted cardiac devices. To the authors' knowledge, there are no in vivo data to support this claim. OBJECTIVE: In this study, the authors aim to describe the outcomes of hyfrecation during dermatologic procedures in patients with pacemakers and implantable cardiac devices. METHODS: Retrospective chart review was completed from March 2014 to April 2018 at a single center. Forty-five patients met criteria of having a cardiac device and having undergone an electrosurgery procedure using the Conmed 2000 Hyfrecator (Utica, NY). Adverse perioperative and postoperative outcomes, as well as device malfunction, were evaluated. RESULTS: No adverse perioperative effects were reported. Device reports were examined for inappropriate firing of the defibrillator, loss of capture, temporary inhibition of pacing, battery drainage, pacing at an elevated or erratic rate, failure to deliver antitachycardia, reversion to asynchronous pacing, induction of arrhythmias, or tissue damage at lead tissue, but no such issues were found. CONCLUSION: The lack of complications associated with cardiac devices with hyfrecation is reassuring. However, prospective and larger retrospective studies are warranted.
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Desfibriladores Implantables , Electrocirugia/instrumentación , Hemostasis Quirúrgica/instrumentación , Cirugía de Mohs/instrumentación , Marcapaso Artificial , Enfermedades de la Piel/cirugía , Anciano , Femenino , Humanos , Masculino , Estudios Retrospectivos , Factores de RiesgoRESUMEN
PURPOSE: We studied fissure status and devices used to divide lung parenchyma during thoracoscopic pulmonary lobectomy (TPL). METHODS: 52 consecutive TPL indicated for congenital pulmonary airway malformation or interlobar pulmonary sequestration performed between 2009 and 2019 were reviewed prospectively to compare patients with absent fissure and no visible interlobar pulmonary artery (IPA) treated by stapling (group A; n = 10), incomplete fissure with partially visible IPA treated with an Enseal® or LigaSure™ device (group I; n = 17), and complete fissure with fully visible IPA treated by electrocautery (group C; n = 25). RESULTS: Patient demographics were similar. Mean age at TPL was 2.82 years (range 0.03-9.81). Mean duration of follow-up was 4.77 years (range 0.33-10.19). Operative time and duration of chest tube insertion were similar (p = NS). Intraoperative blood loss was significantly lower in group C compared with group I (p = 0.028). Complications were minor bronchial artery hemorrhage during anterior-to-posterior bronchial dissection (group A: n = 1; group I: n = 1), problematic single lung ventilation (group I: n = 1), and persistent postoperative air leak (group I: n = 1). CONCLUSION: While fissure status does not appear to affect the outcome of TPL in children, the choice of device for dividing lung parenchyma relies specifically on fissure status.
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Pulmón/patología , Pulmón/cirugía , Neumonectomía/métodos , Toracoscopía , Pérdida de Sangre Quirúrgica , Niño , Preescolar , Electrocoagulación , Femenino , Hemostasis Quirúrgica/instrumentación , Humanos , Lactante , Recién Nacido , Masculino , Complicaciones Posoperatorias , Estudios Prospectivos , Grapado QuirúrgicoRESUMEN
OBJECTIVE: To describe a resection technique of the alar folds in the standing horse. STUDY DESIGN: Retrospective case study. ANIMALS: Eight Standardbred racing trotters. METHODS: Horses in which alar fold collapse had been diagnosed between 2017 and 2018 were included in this study. All horses underwent alar fold resection under standing sedation and regional anesthesia with a bipolar electrosurgical open sealer/divider device (LigaSure). Intraoperative and postoperative complications were recorded. A Wilcoxon signed-rank test was used to compare differences in median prize money earning pre-surgery and post-surgery (P < .05). RESULTS: The surgical procedure was short (20-30 min), with minimal (1/8) to no (7/8) bleeding and was well tolerated in all cases. Complete resection of the alar folds along with 3 to 5 cm of the ventral conchal cartilage was achieved. No complications were observed post-surgery with satisfactory second intention healing, allowing return to training/racing within 3 to 6 weeks post-surgery in all cases. Median earnings post-surgery increased (P = .03) compared with pre-surgery. CONCLUSION: Alar fold resection with bipolar electrosurgical energy offered a good alternative to the traditional surgical approaches performed under general anesthesia. The surgery significantly improved race earnings and performance while avoiding the risk associated with general anesthesia and offered a short and complication-free rehabilitation period. CLINICAL IMPACT: This study describes a surgical technique offering a novel approach to resection of the alar folds in the standing horse.
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Obstrucción de las Vías Aéreas/veterinaria , Electrocoagulación/instrumentación , Hemostasis Quirúrgica/instrumentación , Enfermedades de los Caballos/cirugía , Instrumentos Quirúrgicos/veterinaria , Parálisis de los Pliegues Vocales/veterinaria , Obstrucción de las Vías Aéreas/cirugía , Animales , Femenino , Hemostasis Quirúrgica/métodos , Caballos , Masculino , Cartílagos Nasales/cirugía , Complicaciones Posoperatorias/veterinaria , Estudios Retrospectivos , Parálisis de los Pliegues Vocales/cirugíaRESUMEN
Blakemore probe-obturator was previously preferable for primary hemostasis in patients with bleeding from esophageal varices. Currently, Danis self-expanding nitinol stent became an effective alternative. According to some manufacturers, Danis stent has some advantages over balloon tamponade. We report implantation of nitinol stent for hemostasis in a patient with multiple recurrent bleeding and ineffective endoscopic manipulations. A method of stent fixation for prevention of distal migration as the most common complication is described.
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Várices Esofágicas y Gástricas , Hemorragia Gastrointestinal , Hipertensión Portal , Aleaciones , Materiales Biocompatibles , Várices Esofágicas y Gástricas/diagnóstico , Várices Esofágicas y Gástricas/etiología , Várices Esofágicas y Gástricas/cirugía , Esofagoscopía , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/cirugía , Hemostasis Quirúrgica/instrumentación , Humanos , Hipertensión Portal/complicaciones , Hipertensión Portal/diagnóstico , Falla de Prótesis , Implantación de Prótesis/métodos , StentsRESUMEN
BACKGROUND: Ultrasonic or bipolar radiofrequency energy devices are routinely used for dissection and hemostasis during thyroidectomy. We report a single-center, prospective, randomized controlled trial comparing the utility and outcomes of Harmonic Focus, an ultrasonic coagulating shear device (UCSD), versus Ligasure Small Jaw, an electrothermal bipolar vessel sealer (EBVS) in thyroidectomy (NCT01765686). METHODS: Between December 2012 to January 2016, eligible patients were randomized to undergo hemithyroidectomy using either a UCSD or an EBVS. The primary outcome was duration of surgery. Secondary outcomes included blood loss, postoperative complications, ease of device use, ease of device set-up, vocal cord function, postoperative wound drainage, pain score, and adverse events. RESULTS: Of 110 patients assessed for eligibility, 100 were randomly allocated (UCSD: 49 patients; EBVS: 51 patients) and analyzed by intention-to-treat. There were no differences in specimen delivery time, total duration of surgery, wound drainage, and adverse events between the two groups. The UCSD group had a greater proportion of patients with higher postoperative pain scores in the first 72 h (8.1% vs. 2.0%, p = 0.043). Surgeons reported greater ease of use for the UCSD (49% vs. 27%; p = 0.005), while operating room staff favored the EBVS (60% vs. 33%, p = 0.005). CONCLUSIONS: Energy devices are equally effective in reducing thyroidectomy operative times, with no differences in the duration of surgery, drainage, or adverse events. Use of the UCSD was associated with higher postoperative pain scores, but was favored by the surgeons, likely due to the ability to perform fine dissection with the device itself.
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Electrocoagulación/instrumentación , Hemostasis Quirúrgica/instrumentación , Enfermedades de la Tiroides/cirugía , Tiroidectomía/instrumentación , Terapia por Ultrasonido/instrumentación , Adulto , Anciano , Pérdida de Sangre Quirúrgica/prevención & control , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Dolor Postoperatorio/prevención & control , Complicaciones Posoperatorias/prevención & control , Estudios Prospectivos , Instrumentos QuirúrgicosRESUMEN
BACKGROUND AND AIMS: Many new through-the-scope clips are available, and physicians often select clips based on physical characteristics and/or cost. However, functional profiles may be equally important and have not been methodically assessed. We evaluated 5 commercially available clips: Resolution 360, Instinct, Quick Clip Pro, Dura Clip, and SureClip. METHODS: We rigorously compared clips on multiple characteristics, including rotatability, overshoot, open/close precision, and tensile/closure strength. Clips were tested in 4 different endoscope configurations: (1) straight, (2) duodenal sweep, (3) full retroflexion, and (4) across the duodenoscope elevator. RESULTS: For rotatability, the Resolution 360 was the fastest due to its unique functionality in allowing primary MD control in rotation (P < .05). The Resolution 360, SureClip, and Dura Clip were able to rotate through the prescribed sequence across all scope configurations. For overshoot, the SureClip and Resolution 360 had the least overshoot for the straight configuration at 0%. All clips had >75% overshoot at more strained configurations. For open/close precision, the SureClip and Dura Clip showed precise opening/closing with the ability to stop at any point. The remaining clips exhibited abrupt opening with more controlled closure. For tensile strength, the Quick Clip Pro generated the highest peak force as would be required in lateral tissue manipulation (4.8 lb, P < .005). For closure strength, the Instinct overall showed the most gel compression, and along with the Resolution 360, showed 100% deployment success for all gel tissue thicknesses (up to 10 mm). CONCLUSIONS: Each clip has a unique physical and functional profile, which may be a factor in selection depending on the clinical circumstance.