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1.
Trials ; 25(1): 122, 2024 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-38355562

RESUMO

BACKGROUND: Anorectal fistula, which is a relatively common pathology, is the chronic manifestation of the acute perirectal process that forms an anal abscess. The development of a fistula after incision and drainage of an anal abscess is seen in approximately 26-37%. Its treatment is a relevant topic, and the role of the use of antibiotic therapy in its prevention remains controversial, after the publication of several studies with contradictory results and several methodological limitations. Our hypothesis is that the combination of amoxicillin and clavulanic acid will reduce the incidence of anal fistula. METHOD: The aim of this study is to evaluate the efficacy of antibiotherapy after surgical drainage of perianal abscess in the development of perianal fistula. The PERIQxA study is a multicenter, randomized, double-blind controlled trial. The study has been designed to include 286 adult patients who will be randomly (1:1) assigned to either the experimental (amoxicillin/clavulanic acid 875/125 mg TDS for 7 days) or the control arm (placebo). The primary outcome measure is the percentage of patients that develop perianal fistula after surgery and during follow-up (6 months). DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of amoxicillin/clavulanic in the prevention of perianal fistula. The results of this study are expected to contribute to stablish the potential role of antibiotherapy in the therapeutics for anal abscess. TRIAL REGISTRATION: EudraCT Number: 2021-003376-14. Registered on November 26, 2021.


Assuntos
Doenças do Ânus , Fístula Retal , Dermatopatias , Adulto , Humanos , Abscesso/diagnóstico , Abscesso/etiologia , Abscesso/prevenção & controle , Combinação Amoxicilina e Clavulanato de Potássio/efeitos adversos , Doenças do Ânus/complicações , Doenças do Ânus/prevenção & controle , Doenças do Ânus/cirurgia , Fístula Retal/diagnóstico , Fístula Retal/etiologia , Fístula Retal/prevenção & controle , Drenagem/efeitos adversos , Drenagem/métodos , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
Contemp Clin Trials Commun ; 22: 100806, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34195471

RESUMO

BACKGROUND: Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves' Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. METHODS: A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. CONCLUSIONS: There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03980132.

3.
Surgery ; 170(4): 1112-1119, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34020792

RESUMO

BACKGROUND: Management of subcostal incisional hernias is particularly complicated due to their proximity to the costochondral limits in addition to the lack of aponeurosis on the lateral side of the abdomen. We present our results of posterior component separation through the same previous incision as a safe and reproducible technique for these complex cases. METHODS: We present a multicenter and prospective cohort of patients diagnosed with bilateral subcostal incisional hernias on either clinical examination or imaging based on computed tomography from 2014 to 2020. The aim of this investigation was to assess the outcomes of abdominal wall reconstruction for subcostal incisional hernias through a new approach. The outcomes reported were short- and long-term complications, including recurrence, pain, and bulging. Quality of life was assessed with the European Registry for Abdominal Wall Hernias Quality of Life score. RESULTS: A total of 46 patients were identified. All patients underwent posterior component separation. Surgical site occurrences occurred in 10 patients (22%), with only 7 patients (15%) requiring procedural intervention. During a mean follow-up of 18 (range, 6-62), 1 (2%) case of clinical recurrence was registered. In addition, there were 8 (17%) patients with asymptomatic but visible bulging. The European Registry for Abdominal Wall Hernias Quality of Life score showed a statistically significant decrease in the 3 domains (pain, restriction, and cosmetic) of the postoperative compared with the preoperative scores. CONCLUSION: Posterior component separation technique for the repair of subcostal incisional hernias through the same incision is a safe procedure that avoids injury to the linea alba. It is associated with acceptable morbidity, low recurrence rate, and improvement in patients' reported outcomes.


Assuntos
Músculos Abdominais/cirurgia , Abdominoplastia/métodos , Hérnia Ventral/cirurgia , Herniorrafia/métodos , Hérnia Incisional/cirurgia , Telas Cirúrgicas , Feminino , Hérnia Ventral/diagnóstico , Hérnia Ventral/etiologia , Humanos , Hérnia Incisional/complicações , Hérnia Incisional/diagnóstico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Reoperação , Tomografia Computadorizada por Raios X
4.
Gastroenterol. hepatol. (Ed. impr.) ; 43(8): 426-430, oct. 2020. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-196893

RESUMO

OBJETIVOS: La tendencia actual en el tratamiento de la diverticulitis aguda no complicada es el manejo ambulatorio de los pacientes con pautas cortas de antibiótico o incluso con antiinflamatorios en casos seleccionados. Presentamos una comparativa de los resultados obtenidos en nuestro hospital con distintos protocolos aplicados en 2016 y 2017. MATERIAL Y MÉTODOS: Todos los pacientes seleccionados para este estudio fueron diagnosticados de diverticulitis grado Ia de la clasificación de Hinchey, según los hallazgos radiológicos en la TC abdominal. Hemos analizado dos cohortes retrospectivas: 100 pacientes tratados en 2016 según protocolo antiguo y 104 pacientes tratados en 2017 con protocolo nuevo. En el año 2016 los pacientes candidatos a tratamiento ambulatorio permanecieron en observación durante 24 horas antes de ser dados de alta. El tratamiento consistió en 14 días de ciprofloxacino y metronidazol. En 2017 solo se observaron durante 24 horas los pacientes con sintomatología más aguda y se prescribió amoxicilina-clavulánico durante solo cinco días. RESULTADOS: La persistencia de la enfermedad en 2016 fue del 6% y en 2017 solo alcanzó el 5,77% (p = 0,944). La recidiva durante el primer año fue del 13% en el primer grupo, mientras que en el segundo fue del 5,7%, aunque esta diferencia no fue estadísticamente significativa. Asimismo, se consiguió una significativa reducción del coste sanitario. CONCLUSIONES: El tratamiento ambulatorio de la diverticulitis aguda no complicada con pauta corta de antibiótico oral parece ser una estrategia terapéutica segura y efectiva en pacientes seleccionados con escasa comorbilidad


GOALS: The current trend in the treatment of non-complicated diverticulitis is the outpatient management with antibiotic or even anti-inflammatory regimens in selected cases. We present a comparison of the results in our hospital with different protocols applied in 2016 and 2017. MATERIAL AND METHODS: All patients selected for this study were diagnosed with diverticulitis grade Ia of Hinchey's classification according to radiological findings on abdominal CT. We have analyzed two retrospective cohorts: 100 patients treated in 2016 according to the old protocol and 104 patients treated in 2017 with a new protocol. In 2016, the candidates for ambulatory treatment remained under observation for 24 hours before being discharged. The treatment consisted of 14 days of ciprofloxacin and metronidazole. In 2017, only patients with more acute symptoms were observed 24 hours and amoxicillin-clavulanic acid was prescribed for only 5 days. RESULTS: The persistence of the disease in 2016 was 6% and in 2017 was only 5.77% (p = 0.944). Recurrence during the first year was 13% in the first group, while in the second it was 5.7%, although this difference was not statistically significant. Likewise, a significant reduction in health costs was achieved. CONCLUSIONS: Outpatient treatment of acute uncomplicated diverticulitis with oral treatment seems to be a safe and effective therapeutic strategy in selected patients with low comorbidity


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Diverticulite/tratamento farmacológico , Resultado do Tratamento , Assistência Ambulatorial/métodos , Estudos de Coortes , Estudos Retrospectivos , Ciprofloxacina/administração & dosagem , Metronidazol/administração & dosagem , Combinação Amoxicilina e Clavulanato de Potássio/administração & dosagem
5.
Gastroenterol Hepatol ; 43(8): 426-430, 2020 Oct.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-32434733

RESUMO

GOALS: The current trend in the treatment of non-complicated diverticulitis is the outpatient management with antibiotic or even anti-inflammatory regimens in selected cases. We present a comparison of the results in our hospital with different protocols applied in 2016 and 2017. MATERIAL AND METHODS: All patients selected for this study were diagnosed with diverticulitis grade Ia of Hinchey's classification according to radiological findings on abdominal CT. We have analyzed two retrospective cohorts: 100 patients treated in 2016 according to the old protocol and 104 patients treated in 2017 with a new protocol. In 2016, the candidates for ambulatory treatment remained under observation for 24 hours before being discharged. The treatment consisted of 14 days of ciprofloxacin and metronidazole. In 2017, only patients with more acute symptoms were observed 24 hours and amoxicillin-clavulanic acid was prescribed for only 5 days. RESULTS: The persistence of the disease in 2016 was 6% and in 2017 was only 5.77% (p = 0.944). Recurrence during the first year was 13% in the first group, while in the second it was 5.7%, although this difference was not statistically significant. Likewise, a significant reduction in health costs was achieved. CONCLUSIONS: Outpatient treatment of acute uncomplicated diverticulitis with oral treatment seems to be a safe and effective therapeutic strategy in selected patients with low comorbidity.


Assuntos
Diverticulite/tratamento farmacológico , Doença Aguda , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
6.
Endocrinol. diabetes nutr. (Ed. impr.) ; 66(3): 195-201, mar. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-182620

RESUMO

Introducción: El hipoparatiroidismo permanente es la complicación a largo plazo más prevalente tras una tiroidectomía total, siendo responsable de una importante morbilidad y de necesidad de tratamiento sustitutivo a largo plazo. El objetivo de este estudio fue determinar si el valor de la hormona paratiroidea intacta (PTHi) en el primer día postoperatorio tras una tiroidectomía total es un buen predictor de hipoparatiroidismo permanente. Material y métodos: Estudio retrospectivo de observación en el que se analizaron todos los pacientes intervenidos de tiroidectomía total entre enero de 2009 y diciembre de 2014. Se recogieron los valores de PTHi y calcio sérico en el primer día postoperatorio, y todos los pacientes tuvieron un seguimiento mínimo de un año. Resultados: Se incluyeron 481 pacientes con una edad media de 53±14 años, el 82% de los cuales eran mujeres. La causa más frecuente de tiroidectomía fue el bocio multinodular (75%), seguido del carcinoma papilar de tiroides (15%). La complicación precoz más frecuente fue la hipocalcemia transitoria (49%), y a largo plazo fue el hipoparatiroidismo permanente (6%). El estudio estadístico mediante curvas ROC mostró que la PTHi en el primer día postoperatorio es un buen predictor de hipoparatiroidismo permanente (área bajo la curva de 0,87; IC 95%: 0,84-0,91). Valores de 5pg/ml presentan una sensibilidad del 95%, una especificidad del 77%, un valor predictivo positivo del 21,6% y un valor predictivo negativo del 99,6%. Conclusiones: La PTHi en el primer día postoperatorio de la tiroidectomía total es un predictor útil de hipoparatiroidismo permanente gracias a su alto valor predictivo negativo. Valores de PTHi>5 pg/ml excluyen prácticamente la presencia de hipoparatiroidismo permanente


Background: Permanent hypoparathyroidism is the most common long-term complication after total thyroidectomy, causing significant morbidity and requiring long-term replacement therapy. Our study objective was to assess whether intact parathyroid hormone (iPTH) levels on the first day after total thyroidectomy are a good predictor of permanent hypoparathyroidism. Patients and methods: A retrospective observational study of all patients undergoing total thyroidectomy between January 2009 and December 2014. iPTH and calcium levels were measured the first day after surgery. Patients were followed up for at least one year after surgery. Results: The study group consisted of 481 patients with a mean age of 53±14 years, 82% of them females. The most common reason for thyroidectomy was multinodular goiter (75%), followed by papillary thyroid cancer (15%). Transient hypocalcemia was the most common early complication after total thyroidectomy (49%), and permanent hypoparathyroidism was the most common long-term complication (6%). ROC curve analysis showed that iPTH level on the first postoperative day was a good predictor of permanent hypoparathyroidism (area under the curve 0.87; 95% CI: 0.84-0.91). Cut-off iPTH levels of 5pg/mL had 95% sensitivity, 77% specificity, 21.6% positive predictive value, and 99.6% negative predictive value. Conclusions: iPTH level on the first day after total thyroidectomy is a useful predictor of permanent hypoparathyroidism because of its high negative predictive value. Serum iPTH levels >5pg/mL virtually exclude presence of permanent hypoparathyroidism


Assuntos
Humanos , Adulto , Pessoa de Meia-Idade , Masculino , Feminino , Idoso , Hormônio Paratireóideo/análise , Hipoparatireoidismo/diagnóstico , Período Pós-Operatório , Estudos Retrospectivos , Curva ROC , Valor Preditivo dos Testes , Hipocalcemia/complicações , 28599
7.
Endocrinol Diabetes Nutr (Engl Ed) ; 66(3): 195-201, 2019 Mar.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30392997

RESUMO

BACKGROUND: Permanent hypoparathyroidism is the most common long-term complication after total thyroidectomy, causing significant morbidity and requiring long-term replacement therapy. Our study objective was to assess whether intact parathyroid hormone (iPTH) levels on the first day after total thyroidectomy are a good predictor of permanent hypoparathyroidism. PATIENTS AND METHODS: A retrospective observational study of all patients undergoing total thyroidectomy between January 2009 and December 2014. iPTH and calcium levels were measured the first day after surgery. Patients were followed up for at least one year after surgery. RESULTS: The study group consisted of 481 patients with a mean age of 53±14 years, 82% of them females. The most common reason for thyroidectomy was multinodular goiter (75%), followed by papillary thyroid cancer (15%). Transient hypocalcemia was the most common early complication after total thyroidectomy (49%), and permanent hypoparathyroidism was the most common long-term complication (6%). ROC curve analysis showed that iPTH level on the first postoperative day was a good predictor of permanent hypoparathyroidism (area under the curve 0.87; 95% CI: 0.84-0.91). Cut-off iPTH levels of 5pg/mL had 95% sensitivity, 77% specificity, 21.6% positive predictive value, and 99.6% negative predictive value. CONCLUSIONS: iPTH level on the first day after total thyroidectomy is a useful predictor of permanent hypoparathyroidism because of its high negative predictive value. Serum iPTH levels >5pg/mL virtually exclude presence of permanent hypoparathyroidism.


Assuntos
Hipoparatireoidismo/sangue , Hormônio Paratireóideo/sangue , Complicações Pós-Operatórias/sangue , Tireoidectomia/efeitos adversos , Adulto , Idoso , Cálcio/sangue , Feminino , Bócio Nodular/cirurgia , Doença de Graves/cirurgia , Humanos , Hipoparatireoidismo/etiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Período Pós-Operatório , Estudos Retrospectivos , Neoplasias da Glândula Tireoide/cirurgia
8.
Cir Cir ; 86(2): 148-151, 2018.
Artigo em Espanhol | MEDLINE | ID: mdl-29809182

RESUMO

Jejunal diverticular disease is a very uncommon pathology often asymptomatic. Associated complications appear in less than 30% of patients and they can present as diverticulitis, refractary inflammation, obstruction, hemorrhage, perforation or intraabdominal abscess formation. Clinical manifestations are usually unspecific and high suspicion index is required to reach the diagnosis. Treatment of complications includes volume replacement, transfusions, antibiotic therapy, percutaneous drainage or surgical intervention. We present a retrospective observational study of the cases treated in our hospital between 2007 and 2016.


La enfermedad diverticular yeyunal es una condición clínica muy poco frecuente y habitualmente asintomática. Las complicaciones asociadas aparecen en menos del 30% de los pacientes y pueden manifestarse como inflamación de los divertículos, obstrucción intestinal, hemorragia digestiva, malabsorción intestinal, formación de abscesos intraabdominales y perforación. La clínica de los pacientes es muchas veces inespecífica, requiriendo un alto grado de sospecha para llegar al diagnóstico. El tratamiento de las complicaciones de la enfermedad diverticular es variado, incluyendo reposición de volumen o transfusiones, antibioticoterapia, drenaje percutáneo o intervención quirúrgica. Presentamos un estudio observacional retrospectivo de los casos tratados en nuestro hospital entre 2007 y 2016.


Assuntos
Diverticulite/diagnóstico , Diverticulite/terapia , Doenças do Jejuno/diagnóstico , Doenças do Jejuno/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Estudos Retrospectivos
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