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1.
Br J Surg ; 107(9): 1130-1136, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32239495

RESUMEN

BACKGROUND: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. METHODS: This was a propensity score-matched case-control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. RESULTS: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. CONCLUSION: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.


ANTECEDENTES: Es esencial identificar los productos subóptimos referidos a las mallas para mejorar los resultados en la cirugía de la hernia. Este estudio analizó si un registro clínico nacional combinado con registros de bases de datos administrativos puede servir como herramienta para la evaluación post-comercialización de productos de mallas para cirugía de la hernia. MÉTODOS: Se efectuó un estudio de emparejamiento por puntaje de propensión de una cohorte de casos y controles en el que se comparaban los resultados de la malla Physiomesh® frente a cualquier otra malla sintética en pacientes sometidos a una reparación laparoscópica de una eventración. Se combinaron los datos de los pacientes del registro danés de hernia entre 2010 y 2016 con los datos administrativos del registro nacional de pacientes de Dinamarca. La variable principal fue la reintervención por recidiva. Las variables secundarias fueron el reingreso a 30 días, la reoperación a 30 días por complicaciones (excluyendo la recidiva de la hernia) y la mortalidad a 30 y 90 días. RESULTADOS: Para la reparación herniaria se utilizó la malla Physiomesh® en 740 pacientes, que se emparejaron mediante el análisis por puntaje de propensión con 1.479 pacientes en los que se colocó otra malla sintética. La reintervención por recidiva herniaria fue significativamente mayor en el grupo Physiomesh® (12,8%) que en el grupo de referencia (6,3%); cociente de riesgos instantáneos (hazard ratio, HR): 2,09 (i.c. del 95%: 1,57-2,79), P < 0,001. El riesgo de reingreso (razón de oportunidades, odds ratio, OR: 1,53, 1,16-2,01, P = 0,002)) y de reoperación por una complicación (OR: 1,60, 1,03-2,47, P = 0,030) fueron superiores en el grupo Physiomesh®. No hubo diferencia en la mortalidad. CONCLUSIÓN: Los grandes registros clínicos con datos recogidos de forma prospectiva pueden ser útiles para efectuar el seguimiento a largo plazo de una malla comercializada para garantizar la seguridad del producto y su calidad quirúrgica. La reparación laparoscópica de una eventración con la malla Physiomesh® se asociaba con un riesgo doble de recidiva y un aumento de la tasa de complicaciones a corto plazo.


Asunto(s)
Hernia Incisional/cirugía , Laparoscopía/efectos adversos , Mallas Quirúrgicas/efectos adversos , Anciano , Estudios de Casos y Controles , Bases de Datos como Asunto , Dinamarca/epidemiología , Femenino , Humanos , Hernia Incisional/mortalidad , Laparoscopía/mortalidad , Laparoscopía/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Vigilancia de Productos Comercializados/métodos , Puntaje de Propensión , Recurrencia , Sistema de Registros , Reoperación/estadística & datos numéricos
2.
Surg Endosc ; 33(9): 2873-2879, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-30421082

RESUMEN

BACKGROUND: Although the internal hernia is rare after gastric cancer surgery, it is a serious complication, and prompt surgical treatment is essential. However, internal hernia has not been studied because of low incidence and difficulty of diagnosis. This study investigated the clinical characteristics and proper management of internal hernia after gastrectomy. METHODS: From June 2001 to June 2016, patients who underwent gastrectomy, either open or laparoscopic (robotic) surgery, with potential internal hernia defect were enrolled. The hernia defect was not closed in any of the enrolled patients. The clinicopathological data of internal hernia patients were compared to patients without internal hernia to identify risk factors. Surgical outcomes of internal hernia were compared between patients who underwent early and late intervention group according to time interval from symptom onset to operation. RESULTS: Of 5777 patients who underwent gastrectomy with possible internal hernia, 24 (0.4%) underwent emergency or scheduled surgery for internal hernia. Internal hernia through the Petersen space was observed in 15 cases, and through the jejunojejunostomy mesenteric defect in 9 cases. Low body mass index (odds ratio [OR] 4.403, p = 0.003) and laparoscopic approach (OR 6.930 p < 0.001) were statistically significant factors in multivariate analysis. Postoperative complication rate (16.7% vs. 50% p = 0.083) and mortality rate (8.3% vs. 25.0% p = 0.273) were slightly higher in the late intervention group. CONCLUSIONS: Although internal hernia is a rare complication, it is difficult to diagnose and cause serious complications. To prevent internal hernia, the necessity of hernia defect closure should be investigated in the further studies. Early surgical treatment is necessary when it is suspected.


Asunto(s)
Gastrectomía/efectos adversos , Hernia Incisional , Neoplasias Gástricas/cirugía , Anastomosis en-Y de Roux/efectos adversos , Estudios de Casos y Controles , Femenino , Gastrectomía/métodos , Humanos , Incidencia , Hernia Incisional/diagnóstico , Hernia Incisional/etiología , Hernia Incisional/mortalidad , Hernia Incisional/cirugía , Laparoscopía/métodos , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , República de Corea/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Neoplasias Gástricas/patología , Resultado del Tratamiento
3.
J Surg Res ; 209: 17-29, 2017 03.
Artículo en Inglés | MEDLINE | ID: mdl-28032555

RESUMEN

BACKGROUND: European Hernia Society guidelines suggested that the evidence of mesh augmentation for the prevention of incisional hernia (IH) was weak. In addition, previous systematic reviews seldom focused on quality of life and cost-effectiveness related to mesh placement. Therefore, an updated meta-analysis was performed to clarify quality of life, cost-effectiveness, the safety, and effectiveness of mesh reinforcement in preventing the incidence of IH. METHODS: Embase, Pubmed, and the Cochrane library were searched from the inception to May 2016 without language limitation for randomized controlled trials (RCTs) which explored mesh reinforcement for the prevention of IH in patients undergoing abdominal surgeries. RESULTS: Twelve RCTs totaling 1661 patients (958 in mesh, 703 in nonmesh) were included in our study. Compared with nonmesh, mesh reinforcement can effectively decrease the incidence of IH (relative risk: 0.19; 95% CI: 0.09-0.42). Besides, mesh placement was associated with improved quality of life, a higher rate of seroma (relative risk: 1.64; 95% CI: 1.13-2.37), and longer operating time (mean difference: 17.62; 95% CI: 1.44-33.80). No difference can be found between both groups in postoperative overall morbidity, systemic postoperative morbidity, wound-related morbidity, surgical site infection, hematoma, wound disruption, postoperative mortality, and length of hospital stay. CONCLUSIONS: Prophylactic mesh reinforcement may be effective and safe to prevent the formation of IH after abdominal surgery, without impairing quality of life. Thus, preventive mesh should be routinely recommended in high-risk patients.


Asunto(s)
Hernia Incisional/prevención & control , Mallas Quirúrgicas , Análisis Costo-Beneficio , Humanos , Hernia Incisional/mortalidad , Tiempo de Internación , Tempo Operativo , Dolor Postoperatorio , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto
4.
Surg Endosc ; 30(10): 4469-79, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-26895908

RESUMEN

BACKGROUND: Laparoscopic surgery for colonic cancer decreases the incidence of postoperative complications and length of hospital stay as compared with open surgery, while the oncologic outcome remains equivalent. It is unknown whether the surgical approach impacts on the long-term rate of incisional hernia. Furthermore, risk factors for incisional hernia formation are not fully elucidated. The aim of this study was to evaluate the long-term effect of elective open versus laparoscopic surgery for colonic cancer on development of incisional hernia. METHODS: This nationwide cohort study included patients operated on electively for colonic cancer with primary anastomosis in Denmark from 2001 to 2008. Patient data were obtained from the database of the Danish Colorectal Cancer Group and merged with data from the National Patient Registry. Multivariable Cox regression and competing risks analysis were performed. RESULTS: A total of 8489 patients were included, with a median follow-up of 8.8 (interquartile range 7.0-10.7) years. The incidence of incisional hernia was increased among patients operated on with open techniques compared with patients undergoing laparoscopic surgery (7.3 vs. 5.2 %, p < 0.001). After adjustment for confounders, laparoscopic approach was associated with a decreased risk of incisional hernia formation (hazard ratio [HR] 0.62, 95 % confidence interval [CI] 0.44-0.89; p = 0.009). Other factors associated with increased risk of incisional hernia were wound infection, fascial dehiscence, anastomotic leak, and body mass index >25 kg/m(2). CONCLUSIONS: This nationwide analysis demonstrated that laparoscopic as compared with open access for curative resection of colonic cancer was associated with a decreased risk of incisional hernia formation.


Asunto(s)
Neoplasias del Colon/cirugía , Hernia Incisional/epidemiología , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Dinamarca/epidemiología , Procedimientos Quirúrgicos Electivos/métodos , Femenino , Hernia Ventral/cirugía , Humanos , Incidencia , Hernia Incisional/etiología , Hernia Incisional/mortalidad , Laparoscopía/métodos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Sistema de Registros , Factores de Riesgo
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