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1.
Ned Tijdschr Geneeskd ; 1672023 03 27.
Artículo en Holandés | MEDLINE | ID: mdl-36988927

RESUMEN

BACKGROUND: Skeletal injury following a generalized tonic-clonic insult is rare. It is often missed as patients are unable to adequately express their symptoms in the post-ictal state, the apparent lack of a trauma prior to the insult and the low a priori chance. However, in order to ensure adequate treatment, timely diagnosis of these injuries is of great importance. CASE DESCRIPTION: A 58-year old man had ongoing abdominal pain following a generalized tonic-clonic insult. Radiographic imaging showed these complaints to be the result of a bilateral acetabulum fracture, due to the forceful muscular contractions during the previous insult. Even though it is very rare and is only described 30 times worldwide, it is a potentially life-threatening injury. The patient was transferred to a specialized trauma center where he underwent open reduction and internal fixation. He recovered fully. CONCLUSION: It is important to be aware of possible musculoskeletal injury following a generalized tonic-clonic insult, as timely diagnosis is of great importance for adequate treatment and the patients' prognosis.


Asunto(s)
Epilepsia Tónico-Clónica , Enfermedades Musculoesqueléticas , Fracturas de la Columna Vertebral , Masculino , Humanos , Persona de Mediana Edad , Convulsiones/diagnóstico , Convulsiones/etiología , Fracturas de la Columna Vertebral/cirugía , Concienciación , Confusión
2.
BMC Med Inform Decis Mak ; 21(1): 110, 2021 03 29.
Artículo en Inglés | MEDLINE | ID: mdl-33781253

RESUMEN

BACKGROUND: Inguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness. METHODS: The E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician's knowledge and preference and the patient's preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months. DISCUSSION: The E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective. TRIAL REGISTRATION: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318 .


Asunto(s)
Ortopedia , Toma de Decisiones , Técnicas de Apoyo para la Decisión , Humanos , Estudios Multicéntricos como Asunto , Países Bajos , Participación del Paciente
3.
BMJ Open ; 8(11): e023709, 2018 11 15.
Artículo en Inglés | MEDLINE | ID: mdl-30446574

RESUMEN

INTRODUCTION: The Emergency Management of Severe Burns (EMSB) referral criteria have been implemented for optimal triaging of burn patients. Admission to a burn centre is indicated for patients with severe burns or with specific characteristics like older age or comorbidities. Patients not meeting these criteria can also be treated in a hospital without burn centre. Limited information is available about the organisation of care and referral of these patients. The aims of this study are to determine the burn injury characteristics, treatment (costs), quality of life and scar quality of burn patients admitted to a hospital without dedicated burn centre. These data will subsequently be compared with data from patients with<10% total bodysurface area (TBSA) burned who are admitted (or secondarily referred) to a burn centre. If admissions were in agreement with the EMSB, referral criteria will also be determined. METHODS AND ANALYSIS: In this multicentre, prospective, observational study (cohort study), the following two groups of patients will be followed: 1) all patients (no age limit) admitted with burn-related injuries to a hospital without a dedicated burn centre in the Southwest Netherlands or Brabant Trauma Region and 2) all patients (no age limit) with<10% TBSA burned who are primarily admitted (or secondarily referred) to the burn centre of Maasstad Hospital. Data on the burn injury characteristics (primary outcome), EMSB compliance, treatment, treatment costs and outcome will be collected from the patients' medical files. At 3 weeks and at 3, 6 and 12 months after trauma, patients will be asked to complete the quality of life questionnaire (EuroQoL-5D), and the patient-reported part of the Patient and Observer Scar Assessment Scale (POSAS). At those time visits, the coordinating investigator or research assistant will complete the observer-reported part of the POSAS. ETHICS AND DISSEMINATION: This study has been exempted by the medical research ethics committee Erasmus MC (Rotterdam, The Netherlands). Each participant will provide written consent to participate and remain encoded during the study. The results of the study are planned to be published in an international, peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR6565.


Asunto(s)
Unidades de Quemados , Quemaduras/terapia , Hospitales , Derivación y Consulta , Superficie Corporal , Quemaduras/economía , Quemaduras/epidemiología , Cicatriz , Estudios de Cohortes , Costos de la Atención en Salud , Humanos , Países Bajos/epidemiología , Evaluación de Resultado en la Atención de Salud , Estudios Prospectivos , Calidad de Vida , Lesión por Inhalación de Humo/epidemiología , Triaje
5.
Expert Rev Med Devices ; 14(10): 755-762, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28892412

RESUMEN

INTRODUCTION: The treatment of incompetent truncal veins has been innovated by the introduction of minimally invasive non-thermal non-tumescent (NTNT) techniques. One of these consists of the use of cyanoacrylate glue to occlude the vein lumen by means of the VenaSeal device. Areas covered: This expert-review aims to evaluate NTNT ablation of incompetent saphenous trunks using the VenaSeal device. Expert commentary: Cyanoacrylate adhesive embolization of incompetent truncal veins using the VenaSeal device is a safe and efficacious innovative technique. Further studies are needed to evaluate anatomical and clinical outcomes at long term.


Asunto(s)
Cianoacrilatos/administración & dosificación , Embolización Terapéutica/métodos , Vena Safena , Várices/terapia , Animales , Embolización Terapéutica/efectos adversos , Humanos , Terapia por Láser , Resultado del Tratamiento
6.
Phlebology ; 32(10): 649-657, 2017 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-28403687

RESUMEN

Objective To systematically review all available English literature on mechanochemical endovenous ablation and to report on the anatomical, technical, and clinical success. Methods A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library on mechanochemical endovenous ablation for the treatment of insufficient great and/or small saphenous vein. Methodological quality of the included studies was evaluated using the MINORS score. The primary outcome measure was anatomical success, defined as closure of the treated vein on follow-up duplex ultrasound imaging. Secondary outcomes were technical and clinical success, and major complications defined as deep venous thrombosis, pulmonary embolisms or paresthesia. Results The literature search identified 759 records, of which 13 were included, describing 10 unique cohorts. A total of 1521 veins (1267 great saphenous vein and 254 small saphenous vein) were included, with cohort sizes ranging from 30 to 570 veins. The pooled anatomical success rate after short-term follow up was 92% (95% CI 90-94%) ( n = 1314 veins). After 6 and 12 months these numbers were 92% (95% CI 88-95%) ( n = 284) and 91% (95% CI 86-94%) ( n = 228), respectively. The long-term anatomical success rates at 2 and 3 years were 91% (95% CI 85-95%) ( n = 136) and 87% (95% CI 75-94%) ( n = 48), respectively. Major complications and especially nerve injury were very rare (≤ 0.2%). All studies were of moderate or good quality using the MINORS scoring scale. Conclusions Mechanochemical endovenous ablation using the ClariVein in combination with liquid sclerosant is associated with an anatomical success rate ranging from 87% to 92% and good clinical success. To date, no randomized controlled trials are available studying the anatomical success after mechanochemical ablation, compared to the endothermal ablation. The risk of major complications is very low after the procedure.


Asunto(s)
Procedimientos Endovasculares/métodos , Vena Safena/cirugía , Soluciones Esclerosantes/uso terapéutico , Procedimientos Endovasculares/efectos adversos , Humanos
7.
J Endovasc Ther ; 24(3): 440-446, 2017 06.
Artículo en Inglés | MEDLINE | ID: mdl-28355935

RESUMEN

PURPOSE: To evaluate the SailValve, a new self-expanding deep venous valve concept based on a single polytetrafluoroethylene cusp floating up and down in the bloodstream like a sail, acting as a flow regulator and allowing minimal reflux to reduce thrombogenicity. METHODS: Both iliac veins of 5 pigs were implanted with SailValve devices; the first animal was an acute pilot experiment to show the feasibility of accurately positioning the SailValve via a femoral access. The other 4 animals were followed for 2 weeks (n=2) or 4 weeks (n=2) under a chronic implantation protocol. Patency and valve function were evaluated directly in all animals using ascending and descending phlebography after device placement and at termination in the chronic implant animals. For reasons of clinical relevance, a regimen of clopidogrel and calcium carbasalate was administered. Histological analysis was performed according to a predefined protocol by an independent pathologist. RESULTS: Deployment was technically feasible in all 10 iliac veins, and all were patent directly after placement. No perioperative or postoperative complications occurred. Ascending phlebograms in the follow-up animals confirmed the patency of all valves after 2 or 4 weeks. Descending phlebograms showed full function in 5 of 8 valves. Limited reflux was seen in 1 valve (4-week group), and the function in the remaining 2 valves (2-week group) was insufficient because of malpositioning. No macroscopic thrombosis was noted on histology. Histology in the follow-up groups revealed a progressive inflammatory reaction to the valves. CONCLUSION: This animal study shows the potential of the SailValve concept with sufficient valve function after adequate positioning and no (thrombogenic) occlusions after short-term follow-up. Future research is essential to optimize valve material and long-term patency.


Asunto(s)
Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Vena Ilíaca/cirugía , Válvulas Venosas , Animales , Biopsia , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Femenino , Oclusión de Injerto Vascular/etiología , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/patología , Vena Ilíaca/fisiopatología , Modelos Animales , Flebografía , Proyectos Piloto , Politetrafluoroetileno , Prueba de Estudio Conceptual , Diseño de Prótesis , Sus scrofa , Factores de Tiempo , Grado de Desobstrucción Vascular , Trombosis de la Vena/etiología
8.
Vascular ; 25(1): 105-109, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27189850

RESUMEN

Objective This study evaluated the concept of percutaneous closure of insufficient veins using the VeinScrew principle. Methods The VeinScrew is designed to place a spring-shaped implant that contracts and clamps around the vein. The ability of the device to occlude adequately was tested in a bench model experiment. The feasibility of accurate placement and adequate venous occlusion was evaluated in an animal experiment and in a human cadaveric experiment. Results The VeinScrew implant occluded up to a pressure of 135 mmHg. In vivo studies confirmed that deployment was challenging but technically feasible, and subsequent phlebography showed closure of the vein. The cadaveric study showed that percutaneous placement of the evolved VeinScrew around the great saphenous vein was feasible and accurate. Conclusions The current studies show the feasibility of the VeinScrew concept. Future developments and translational studies are necessary to determine the potential of this technique as a new option in the phlebologist's toolbox.


Asunto(s)
Técnicas Hemostáticas/instrumentación , Vena Safena , Dispositivos de Cierre Vascular , Animales , Cadáver , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Modelos Animales , Vena Safena/diagnóstico por imagen , Porcinos , Ultrasonografía Intervencional , Presión Venosa
9.
J Minim Access Surg ; 12(3): 248-53, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27279397

RESUMEN

BACKGROUND: Laparoscopic colorectal surgery results in less post-operative pain, faster recovery, shorter length of stay and reduced morbidity compared with open procedures. Less or minimally invasive techniques have been developed to further minimise surgical trauma and to decrease the size and number of incisions. This study describes the safety and feasibility of using an umbilical multi-instrument access (MIA) port (Olympus TriPort+) device with the placement of just one 12-mm suprapubic trocar in laparoscopic (double-port) abdominoperineal resections (APRs) in rectal cancer patients. PATIENTS AND METHODS: The study included 20 patients undergoing double-port APRs for rectal cancer between June 2011 and August 2013. Preoperative data were gathered in a prospective database, and post-operative data were collected retrospectively. RESULTS: The 20 patients (30% female) had a median age of 67 years (range 46-80 years), and their median body mass index (BMI) was 26 kg/m2 (range 20-31 kg/m2). An additional third trocar was placed in 2 patients. No laparoscopic procedures were converted to an open procedure. Median operating time was 195 min (range 115-306 min). A radical resection (R0 resection) was achieved in all patients, with a median of 14 lymph nodes harvested. Median length of stay was 8 days (range 5-43 days). CONCLUSION: Laparoscopic APR using a MIA trocar is a feasible and safe procedure. A MIA port might be of benefit as an extra option in the toolbox of the laparoscopic surgeon to further minimise surgical trauma.

10.
J Endovasc Ther ; 23(1): 199-211, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26564912

RESUMEN

PURPOSE: To investigate and compare the anatomical success rates and complications of the treatment modalities for small saphenous vein (SSV) incompetence. METHODS: A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library on the following therapies for incompetence of SSVs: surgery, endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS), steam ablation, and mechanochemical endovenous ablation (MOCA). The search found 49 articles (5 randomized controlled trials, 44 cohort studies) reporting on the different treatment modalities: surgery (n=9), EVLA (n=28), RFA (n=9), UGFS (n=6), and MOCA (n=1). A random-effects model was used to estimate the primary outcome of anatomical success, which was defined as closure of the treated vein on follow-up duplex ultrasound imaging. The estimate is reported with the 95% confidence interval (CI). Secondary outcomes were technical success and major complications [paresthesia and deep vein thrombosis (DVT)], given as the weighted means. RESULTS: The pooled anatomical success rate was 58.0% (95% CI 40.9% to 75.0%) for surgery in 798 SSVs, 98.5% (95% CI 97.7% to 99.2%) for EVLA in 2950 SSVs, 97.1% (95% CI 94.3% to 99.9%) for RFA in 386 SSVs, and 63.6% (95% CI 47.1% to 80.1%) for UGFS in 494 SSVs. One study reported results of MOCA, with an anatomical success rate of 94%. Neurologic complications were most frequently reported after surgery (mean 19.6%) and thermal ablation (EVLA: mean 4.8%; RFA: mean 9.7%). Deep venous thrombosis was a rare complication (0% to 1.2%). CONCLUSION: Endovenous thermal ablation (EVLA/RFA) should be preferred to surgery and foam sclerotherapy in the treatment of SSV incompetence. Although data on nonthermal techniques in SSV are still sparse, the potential benefits, especially the reduced risk of nerve injury, might be of considerable clinical importance.


Asunto(s)
Terapia por Láser , Vena Safena/cirugía , Insuficiencia Venosa/terapia , Ablación por Catéter/efectos adversos , Humanos , Terapia por Láser/efectos adversos , Selección de Paciente , Complicaciones Posoperatorias/etiología , Valor Predictivo de las Pruebas , Medición de Riesgo , Factores de Riesgo , Vena Safena/diagnóstico por imagen , Escleroterapia/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Ultrasonografía Intervencional , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/cirugía
11.
Vascular ; 24(5): 492-500, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26503733

RESUMEN

This study examines the application of near-infrared spectroscopy to noninvasively detect critical limb ischemia using regional hemoglobin oxygen saturation in percentage values and regional hemoglobin oxygen saturation limb-to-arm ratios. The regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios were calculated in 61 patients with critical limb ischemia (group A). Measurements were performed in rest at four fixed spots at the most affected lower limb and at a reference spot at both upper arms. Similar measurements were performed in the left lower limb of 30 age-matched control patients without peripheral arterial disease (group B). The regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios were significantly different at all measured spots between the groups (all p < 0.001), except for the regional hemoglobin oxygen saturation limb-to-arm ratios of the distal vastus lateralis (p = 0.056). However, a broad overlap of individual regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios was found in both groups, which resulted in poor discriminative predictive value of single measurements. Single measurements of regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios at all measured spots have poor discriminative predictive value in detection of critical limb ischemia. Measurement of regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios at any of the measurement spots has no added value in detecting lower limb ischemia in individuals compared with current diagnostic modalities.


Asunto(s)
Isquemia/diagnóstico , Extremidad Inferior/irrigación sanguínea , Oxihemoglobinas/análisis , Enfermedad Arterial Periférica/diagnóstico , Espectroscopía Infrarroja Corta , Extremidad Superior/irrigación sanguínea , Anciano , Anciano de 80 o más Años , Índice Tobillo Braquial , Área Bajo la Curva , Biomarcadores/sangre , Estudios de Casos y Controles , Enfermedad Crítica , Femenino , Humanos , Isquemia/sangre , Isquemia/fisiopatología , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/sangre , Enfermedad Arterial Periférica/fisiopatología , Valor Predictivo de las Pruebas , Curva ROC , Flujo Sanguíneo Regional
12.
Vascular ; 24(2): 144-9, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25972028

RESUMEN

OBJECTIVE: To evaluate the feasibility and anatomical success of endovenous laser ablation (EVLA) of incompetent perforating veins (IPV). METHODS: All 135 consecutive patients with IPV treated with ELVA (intention-to-treat) from January 2008 to December 2013 were included. Up to the end of 2011, an 810-nm laserset (14 W) was used, and afterwards, a 1470-nm laserset (6 W) was introduced. Duplex ultrasound was performed at 6 weeks' follow-up to assess anatomical success. RESULTS: Overall anatomical success at 6 weeks' follow-up was 56%. Anatomical success was 63% after treatment with 810 nm and 45% with 1470 nm (p = 0.035). This difference in the success rate seems associated with the significantly higher amount of energy delivered in the 810 nm cohort (560 J) versus 1470 nm (186 J). Regardless of the type of laser, anatomical success was significantly higher after treatment with more than 400 J (66%) compared with 0-200 J (40%, p = 0.009) and 200-400 J (43%, p = 0.029). Complications were limited to two cases of transient paresthesia. CONCLUSIONS: EVLA of IPVs is safe and feasible. The amount of energy is highly important in achieving anatomical success.


Asunto(s)
Terapia por Láser , Vena Safena/cirugía , Várices/cirugía , Insuficiencia Venosa/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Factibilidad , Femenino , Humanos , Terapia por Láser/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Vena Safena/diagnóstico por imagen , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler Dúplex , Várices/diagnóstico por imagen , Insuficiencia Venosa/diagnóstico por imagen
14.
Trials ; 15: 421, 2014 Oct 29.
Artículo en Inglés | MEDLINE | ID: mdl-25354769

RESUMEN

BACKGROUND: Minimally invasive endothermal techniques, for example, radiofrequency ablation (RFA), have revolutionized the treatment of insufficient truncal veins and are associated with an excellent outcome. The use of thermal energy requires the instillation of tumescent anesthesia around the vein. Mechanochemical endovenous ablation (MOCA™) combines mechanical endothelial damage, using a rotating wire, with simultaneous infusion of a liquid sclerosans. Tumescent anesthesia is not required as no heat is used. Prospective studies using MOCA™ in both great and small saphenous veins showed good anatomical and clinical results with fast postoperative recovery. METHODS/DESIGN: The MESSI trial (Mechanochemical Endovenous ablation versus radiofrequency ablation in the treatment of primary Small Saphenous vein Insufficiency) is a multicenter randomized controlled trial in which a total of 160 patients will be randomized (1:1) to MOCA™ or RFA. Consecutive patients with primary small saphenous vein incompetence, who meet the eligibility criteria, will be invited to participate in this trial. The primary endpoint is anatomic success, defined as occlusion of the treated veins objectified with duplex ultrasonography at 1 year follow-up. Secondary endpoints are post-procedural pain, initial technical success, clinical success, complications and the duration of the procedure. Initial technical success is defined as the ability to position the device adequately, treat the veins as planned and occlude the treated vein directly after the procedure has been proven by duplex ultrasonography. Clinical success is defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS). Power analyses are conducted for anatomical success and post-procedural pain.Both groups will be evaluated on an intention-to-treat principle. DISCUSSION: The hypothesis of the MESSI trial is that the anatomic success rate of MOCA™ is not inferior to RFA. The second hypothesis is that post-procedural pain is significantly less after MOCA compared to RFA. TRIAL REGISTRATION: NTR4613 Date of trial registration: 28 May 2014.


Asunto(s)
Ablación por Catéter , Procedimientos Endovasculares/métodos , Proyectos de Investigación , Vena Safena/cirugía , Soluciones Esclerosantes/administración & dosificación , Escleroterapia , Insuficiencia Venosa/terapia , Ablación por Catéter/efectos adversos , Protocolos Clínicos , Procedimientos Endovasculares/efectos adversos , Humanos , Análisis de Intención de Tratar , Países Bajos , Dolor Postoperatorio/etiología , Soluciones Esclerosantes/efectos adversos , Escleroterapia/efectos adversos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/cirugía
15.
Trials ; 15: 121, 2014 Apr 11.
Artículo en Inglés | MEDLINE | ID: mdl-24726004

RESUMEN

BACKGROUND: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain. METHODS/DESIGN: The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base. DISCUSSION: The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain. TRIAL REGISTRATION: Clinicaltrials NCT01936168.


Asunto(s)
Ablación por Catéter , Procedimientos Endovasculares , Proyectos de Investigación , Vena Safena/cirugía , Escleroterapia , Insuficiencia Venosa/terapia , Actividades Cotidianas , Anestesia , Ablación por Catéter/efectos adversos , Ablación por Catéter/economía , Protocolos Clínicos , Análisis Costo-Beneficio , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/economía , Costos de la Atención en Salud , Humanos , Países Bajos , Dimensión del Dolor , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Estudios Prospectivos , Calidad de Vida , Recuperación de la Función , Reinserción al Trabajo , Escleroterapia/efectos adversos , Escleroterapia/economía , Factores de Tiempo , Resultado del Tratamiento , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/economía , Insuficiencia Venosa/cirugía
16.
J Vasc Surg Venous Lymphat Disord ; 2(3): 282-8, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-26993387

RESUMEN

OBJECTIVE: This study evaluated the feasibility, safety, and 1-year results of mechanochemical endovenous ablation (MOCA) of great saphenous vein (GSV) insufficiency. METHODS: A consecutive 106 patients were treated for primary GSV insufficiency with MOCA by the ClariVein device and polidocanol. The primary outcome measures were technical success, clinical success, and anatomic success after 1 year of follow-up. Secondary outcome measures were postprocedural pain, complications, general- and disease-specific quality of life, and time to return to work. Patients were evaluated with clinical examination and duplex ultrasonography at 6 weeks, 6 months, and 1 year after treatment. RESULTS: The technical success was 99%. The mean postprocedural pain during the first 14 days after treatment was 7.5 mm (interquartile range [IQR], 0.0-10.0 mm) per day on a 0- to 100-mm visual analog scale. The time to return to normal activities and work was 1.0 day (IQR, 0-1.0 day) and 1.0 day (IQR, 1.0-4.0 days), respectively. No major complications were recorded. At 1-year follow-up, the clinical success was 93%. The Venous Clinical Severity Score decreased significantly from 4.0 (IQR, 3.0-5.0) before treatment to 1.0 (IQR, 0-1.0) (P < .001) 1 year after MOCA. At 1 year, 88.2% of the treated GSVs remained occluded as measured by duplex ultrasonography. Twelve patients had a recanalization, of which eight were partial. Disease-specific quality of life and the RAND 36-Item Health Survey scores improved significantly at 1-year follow-up. CONCLUSIONS: MOCA is a safe and effective technique in the treatment of GSV insufficiency with good clinical and anatomic success at 1-year follow-up. The technique is related to low postprocedural pain scores, low complication rate, improved quality of life, and rapid resumption of normal activities and work.

17.
Semin Vasc Surg ; 27(2): 118-36, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25868763

RESUMEN

Lower-limb venous insufficiency resulting from saphenous vein incompetence is a common disorder, increasing with age. For decades, surgical stripping of the great saphenous vein has been the gold standard in varicose vein treatment. The desire to optimize outcomes of treatment and reduce surgical trauma has led to the development of endovenous techniques. Today, several endovenous techniques are available to ablate the saphenous vein segments with abnormal vein valve function. In this review, we discuss the techniques, mechanisms of action, outcomes, and complications of all endovenous treatment modalities for the treatment of symptomatic lower-limb varicose veins.


Asunto(s)
Técnicas de Ablación , Procedimientos Endovasculares , Vena Safena/cirugía , Escleroterapia , Insuficiencia Venosa/cirugía , Válvulas Venosas/cirugía , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/instrumentación , Animales , Enfermedad Crónica , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Diseño de Equipo , Humanos , Vena Safena/patología , Vena Safena/fisiopatología , Escleroterapia/efectos adversos , Escleroterapia/instrumentación , Escleroterapia/métodos , Resultado del Tratamiento , Ultrasonografía Intervencional , Dispositivos de Acceso Vascular , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/fisiopatología , Válvulas Venosas/patología , Válvulas Venosas/fisiopatología
18.
Am Heart J ; 165(5): 793-99, 799.e1, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23622917

RESUMEN

BACKGROUND: Direct comparisons between risk of contrast induced acute kidney injury (CI-AKI) after intra-arterial versus intravenous contrast administration are scarce. We estimated and compared the risk of CI-AKI and its clinical course after both modes of contrast administration in patients who underwent both. METHODS: One hundred seventy patients who received both intra-arterial and intravenous contrast injections within one year between 2001 and 2010 were included. Primary outcome was occurrence of CI-AKI. Secondary outcomes were duration of hospital stay, the need for dialysis, recovery of renal function, and mortality. RESULTS: The risk of CI-AKI was 24/170 (14.0%, 95% CI 9.6-20.2) after intra-arterial contrast injection versus 20/170 (11.7%, 95% CI 7.7-17.5) after intravenous contrast administration, which led to a relative risk of 1.2 (95% CI 0.7-2.1). None of the patients had a need for dialysis. Median duration of hospital stay in CI-AKI patients was 15.0 days (2.5-97.5, percentile 1-92) after intra-arterial and 15.5 days (2.5-97.5, percentile 0-38) after intravenous contrast procedures. Renal function recovered after CI-AKI in 13/24 after intra-arterial and in 10/20 patients after intravenous contrast administration. Mortality risks in CI-AKI patients were slightly higher than in non-CI-AKI patients, hazard ratios 1.6 (95% CI 0.7-3.7) for intra-arterial and 1.7 (95% CI 0.7-4.4) for intravenous contrast administration, adjusted for confounders. CONCLUSION: The risk of CI-AKI, and its clinical course was similar after intra-arterial and intravenous contrast media administration, after adjustment by design for patient-related risk factors.


Asunto(s)
Lesión Renal Aguda/inducido químicamente , Medios de Contraste/efectos adversos , Angiografía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Lesión Renal Aguda/terapia , Medios de Contraste/administración & dosificación , Angiografía Coronaria/métodos , Mortalidad Hospitalaria/tendencias , Humanos , Incidencia , Inyecciones Intraarteriales , Inyecciones Intravenosas , Tiempo de Internación , Países Bajos/epidemiología , Diálisis Renal , Estudios Retrospectivos , Factores de Riesgo
19.
Surg Endosc ; 27(10): 3705-9, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23584821

RESUMEN

BACKGROUND: The debate whether laparoscopic pyloromyotomy (LP) is superior to open pyloromyotomy (OP) remains actual. A recent review showed no benefit between the LP or OP, but in the studied randomized, controlled trials the learning curve was not addressed. Comparing LP including the learning curve with OP after the learning curve is questionable. In previous research, the learning curve of LP was analyzed. It was concluded that the plateau was reached after 35 procedures with a steep decrease in complications when comparing before and after 35 procedures. This study was designed to retrospectively analyze the results obtained in HPS patients after the learning curve in LP has been reached. The results will be compared with results of OP in HPS patients in the same period. METHODS: A retrospective analysis in 106 OP and 57 LP was performed from September 2008 to June 2012. RESULTS: The overall complication rate in the OP group was significantly higher than in the LP group (18% vs. 3.5%, p = 0.012). Also there was a higher major complication rate in the OP group (10.4% vs. 1.7%, p = 0.045). The median time to operate was with 28.5 min in OP and 30.0 min in LP (not significant), whereas the LOS was 2 days in both groups (not significant). CONCLUSION: In this study, a further decline in overall and major complications after the learning curve is seen in the LP group, the tail of the learning curve. The debate whether LP is superior to OP is not finished as long as it is not clear whether the minimally invasive operation is beyond the initial or tail of the learning curve.


Asunto(s)
Laparoscopía/educación , Curva de Aprendizaje , Estenosis Hipertrófica del Piloro/cirugía , Píloro/cirugía , Femenino , Humanos , Lactante , Recién Nacido , Laparoscopía/métodos , Tiempo de Internación/estadística & datos numéricos , Masculino , Tempo Operativo , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Dehiscencia de la Herida Operatoria/epidemiología , Dehiscencia de la Herida Operatoria/cirugía , Infección de la Herida Quirúrgica/epidemiología
20.
J Vasc Surg ; 57(2): 445-50, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23141679

RESUMEN

OBJECTIVE: Thermal ablative techniques of varicose veins carry a risk of heat-related complications, including postoperative pain. Mechanochemical endovenous ablation (MOCA) might avoid these complications and reduce postoperative pain because of the absence of thermal energy. This study evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence. METHODS: Sixty-eight patients with unilateral GSV incompetence were treated with either RFA or MOCA in this prospective observational study. Patients monitored their pain for the first 14 postoperative days on a 100-mm visual analog scale (VAS). They also completed the general (RAND 36-Item Short-Form Health Survey) and disease-specific (Aberdeen Varicose Vein Questionnaire) quality of life questionnaires before and 6 weeks after treatment. RESULTS: Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment (4.8 ± 9.7 mm vs 18.6 ± 17.0 mm; P < .001) (mean VAS over 14 days). The lower postoperative pain score was associated with a significantly earlier return to normal activities (1.2 ± 1.8 vs 2.4 ± 2.8 days; P = .02) and work resumption (3.3 ± 4.7 vs 5.6 ± 5.8 days, respectively; P = .02). At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life. CONCLUSIONS: MOCA is associated with significantly less postoperative pain, faster recovery, and earlier work resumption compared with RFA in the treatment of GSV incompetence. MOCA and RFA are both related to a rapid improvement in quality of life.


Asunto(s)
Ablación por Catéter/efectos adversos , Dolor Postoperatorio/prevención & control , Calidad de Vida , Vena Safena/cirugía , Escleroterapia/efectos adversos , Insuficiencia Venosa/terapia , Adulto , Anciano , Ablación por Catéter/psicología , Distribución de Chi-Cuadrado , Femenino , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Dimensión del Dolor , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/psicología , Polidocanol , Polietilenglicoles/administración & dosificación , Estudios Prospectivos , Sistema de Registros , Vena Safena/fisiopatología , Soluciones Esclerosantes/administración & dosificación , Escleroterapia/psicología , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Insuficiencia Venosa/diagnóstico , Insuficiencia Venosa/fisiopatología , Insuficiencia Venosa/psicología , Insuficiencia Venosa/cirugía
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