RESUMO
BACKGROUND & AIMS: The Primary Biliary Cholangitis (PBC) Obeticholic Acid (OCA) International Study of Efficacy (POISE) randomized, double-blind, placebo-controlled trial demonstrated that OCA reduced biomarkers associated with adverse clinical outcomes (ie, alkaline phosphatase, bilirubin, aspartate aminotransferase, and alanine aminotransferase) in patients with PBC. The objective of this study was to evaluate time to first occurrence of liver transplantation or death in patients with OCA in the POISE trial and open-label extension vs comparable non-OCA-treated external controls. METHODS: Propensity scores were generated for external control patients meeting POISE eligibility criteria from 2 registry studies (Global PBC and UK-PBC) using an index date selected randomly between the first and last date (inclusive) on which eligibility criteria were met. Cox proportional hazards models weighted by inverse probability of treatment assessed time to death or liver transplantation. Additional analyses (Global PBC only) added hepatic decompensation to the composite end point and assessed efficacy in patients with or without cirrhosis. RESULTS: During the 6-year follow-up, there were 5 deaths or liver transplantations in 209 subjects in the POISE cohort (2.4%), 135 of 1381 patients in the Global PBC control (10.0%), and 281 of 2135 patients in the UK-PBC control (13.2%). The hazard ratios (HRs) for the primary outcome were 0.29 (95% CI, 0.10-0.83) for POISE vs Global PBC and 0.30 (95% CI, 0.12-0.75) for POISE vs UK-PBC. In the Global PBC study, HR was 0.20 (95% CI, 0.03-1.22) for patients with cirrhosis and 0.31 (95% CI, 0.09-1.04) for those without cirrhosis; HR was 0.42 (95% CI, 0.21-0.85) including hepatic decompensation. CONCLUSIONS: Patients treated with OCA in a trial setting had significantly greater transplant-free survival than comparable external control patients.
Assuntos
Cirrose Hepática Biliar , Ácido Ursodesoxicólico , Humanos , Ácido Ursodesoxicólico/efeitos adversos , Cirrose Hepática Biliar/diagnóstico , Cirrose Hepática Biliar/tratamento farmacológico , Cirrose Hepática Biliar/cirurgia , Ácido Quenodesoxicólico/efeitos adversos , Cirrose Hepática/complicaçõesRESUMO
BACKGROUND AND AIMS: Patients with primary biliary cholangitis (PBC) and insufficient response to ursodeoxycholic acid (UDCA), currently assessed after 1 year, are candidates for second-line therapy. The aims of this study are to assess biochemical response pattern and determine the utility of alkaline phosphatase (ALP) at six months as a predictor of insufficient response. METHODS: UDCA-treated patients in the GLOBAL PBC database with available liver biochemistries at one year were included. POISE criteria were used to assess response to treatment, defined as ALP <1.67 × upper limit of normal (ULN) and normal total bilirubin at one year. Various thresholds of ALP at six months were evaluated to predict insufficient response based on negative predictive value (NPV) and that with nearest to 90% NPV was selected. RESULTS: For the study, 1362 patients were included, 1232 (90.5%) female, mean age of 54 years. The POISE criteria were met by 56.4% (n = 768) of patients at one year. The median ALP (IQR) of those who met POISE criteria compared to those who did not was 1.05 × ULN (0.82-1.33) vs. 2.37 × ULN (1.72-3.69) at six months (p < .001). Of 235 patients with serum ALP >1.9 × ULN at six months, 89% did not achieve POISE criteria (NPV) after one year of UDCA. Of those with insufficient response by POISE criteria at one year, 210 (67%) had an ALP >1.9 × ULN at six months and thus would have been identified early. CONCLUSIONS: We can identify patients for second-line therapy at six months using an ALP threshold of 1.9 × ULN, given that approximately 90% of these patients are non-responders according to POISE criteria.
Assuntos
Cirrose Hepática Biliar , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Cirrose Hepática Biliar/diagnóstico , Cirrose Hepática Biliar/tratamento farmacológico , Fosfatase Alcalina , Colagogos e Coleréticos/uso terapêutico , Bilirrubina , Ácido Ursodesoxicólico/uso terapêuticoRESUMO
INTRODUCTION AND OBJECTIVE: The implementation of Enhanced Recover After Surgery (ERAS) multimodal rehabilitation protocols in radical cystectomy has shown to improve outcomes in hospital stay and complications. The aim of this analysis is to evaluate the impact of laparoscopic surgery on radical cystectomy within a multimodal rehabilitation program. MATERIAL AND METHODS: The study was carried out in a third level center between 2011 and 2020 including patients with bladder cancer submitted to radical cystectomy according to an ERAS (Enhanced Recovery After Surgery) protocol and the Spanish Multimodal Rehabilitation Group (GERM) with 20 items to be fulfilled. RESULTS: A total of 250 radical cystectomies were performed throughout the study period, 42.8% by open surgery (OS) and 57.2% by laparoscopic surgery (LS). The groups are comparable in demographic and clinical variables (pâ¯>â¯0.05). Operative time was longer in the LS group (248.4⯱â¯55.0 vs. 286.2⯱â¯51.9â¯min; pâ¯<â¯0.001). However, bleeding was significantly lower in the LS group (417.5⯱â¯365.7 vs. 877.9⯱â¯529.7 cc; pâ¯<â¯0.001), as was the need for blood transfusion (33.6% vs. 58.9%; pâ¯<â¯0.001). Postoperative length of stay (11.5⯱â¯10.5 vs. 20.1⯱â¯17.2 days; pâ¯<â¯0.001), total and major complications were also significantly lower in this group (LS). The readmission rate was lower in the LS group but not significantly (36.4% vs. 29.4%; pâ¯=â¯0.237). The difference between 90-day mortality in both groups was not statistically significant (2.8% LS vs. 4.3% OS; pâ¯=â¯0.546). The differences were maintained in the multivariate models. CONCLUSIONS: Laparoscopic surgery within a multimodal rehabilitation program increases operative time but significantly decreases intraoperative bleeding, transfusion requirements, postoperative length of stay, and complications.
Assuntos
Cistectomia , Laparoscopia , Neoplasias da Bexiga Urinária , Humanos , Cistectomia/reabilitação , Cistectomia/métodos , Masculino , Laparoscopia/reabilitação , Feminino , Neoplasias da Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/reabilitação , Idoso , Resultado do Tratamento , Pessoa de Meia-Idade , Recuperação Pós-Cirúrgica Melhorada , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Protocolos Clínicos , Tempo de Internação/estatística & dados numéricos , Terapia CombinadaRESUMO
INTRODUCTION AND OBJECTIVES: Radical cystectomy with urinary diversion associated with extended pelvic lymphadenectomy continues to be the treatment of choice in muscle invasive bladder cancer. Sixty-four percent of patients submitted to this procedure present postoperative complications, with urinary infection being responsible in 20-40% of cases. The aim of this project is to assess the rate of urinary infection as a cause of re-admission after cystectomy, and to identify protective and predisposing factors for urinary infection in our environment. Finally, we will evaluate the outcomes after the establishment of a prophylactic antibiotic protocol after removal of ureteral catheters. MATERIAL AND METHODS: Retrospective descriptive study of cystectomized patients in the Urology Service of the Hospital Clínico Universitario of Zaragoza, from January 2012 to December 2018. A urinary tract infection (UTI) prevention protocol after catheter removal is established for all patients since October 2017. RESULTS: UTI is responsible for 54.7% of readmissions, with 55.1% of these being due to UTI after removal of ureteral catheters. Of the patients who received with prophylaxis, 9.5% presented UTIs after withdrawal, compared to 10.6% in the group of patients without prophylaxis. The patient who is re-admitted for UTI after withdrawal has a mean catheter time of 24.3±7.2 days, compared to 24.5±7.4 days for patients in the group without UTI (P=.847). CONCLUSIONS: The type of urinary diversion performed is not related to the rate of urinary infection. The regression model does not identify antibiotic prophylaxis, nor catheter time, as independent factors of UTI after catheter removal.
Assuntos
Derivação Urinária , Infecções Urinárias , Antibioticoprofilaxia , Cistectomia/efeitos adversos , Humanos , Estudos Retrospectivos , Derivação Urinária/efeitos adversos , Infecções Urinárias/epidemiologiaRESUMO
Report of a 32-year old male patient with an injury of the posterior urethra caused by firearm. Initial examination only revealed fracture of the femoral vein. Absence of spontaneous micturition during the immediate post-operative made necessary to undertake retrograde urethrography, in which a fracture of the posterior urethra with extraperitoneal pelvian extravasation was found. The lack of references on urethral injuries by firearm and the good evolution obtained in this case with a conservative approach, suprapubic cystotomy, had encouraged us to report this case.
Assuntos
Uretra/lesões , Ferimentos por Arma de Fogo , Adulto , Humanos , Masculino , Ferimentos por Arma de Fogo/diagnósticoRESUMO
With the purpose of evaluating the long-term results of percutaneous endoscopic urethrocervicopexy performed in our unit since 1987, using a modified Stamey's technique, in the treatment of stress urinary incontinence in women, 51 patients who had undergone surgery up to June 92 were retrospectively studied. Mean time since surgery was 35 months, and satisfactory results during this time were accomplished in 60.5%, bearing in mind that the patients are totally "dry" and do not require sanitary towels. Comparison of our results and those contributed by other authors in the literature, indicating the decrease over time in the number of good results, and that between three to four years after intervention, the stress urinary incontinence reappears in one third of the women. Finally, we try to provide an statistical correlation of the cases in which continence was not achieved, including the patient's personal features or their medical-surgical background.
Assuntos
Colo do Útero/cirurgia , Uretra/cirurgia , Endoscopia/métodos , Endoscopia/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Recidiva , Espanha/epidemiologia , Fatores de Tempo , Incontinência Urinária por Estresse/epidemiologia , Incontinência Urinária por Estresse/cirurgiaRESUMO
We report on two adolescent girls with imperforate hymen that had presented clinically as urinary retention. In the second case described herein, hydrocolpos could have resulted from the imperforate hymen and might have caused the congenital hydronephrosis incorrectly diagnosed during the neonatal period and childhood as such.
Assuntos
Hematocolpia/complicações , Hímen/anormalidades , Retenção Urinária/etiologia , Adolescente , Feminino , Humanos , Hidronefrose/congênito , Hidronefrose/etiologia , Hímen/cirurgia , Ureter/anormalidades , Refluxo Vesicoureteral/etiologiaRESUMO
OBJECTIVES: Considerations on a case of prenatal torsion of the spermatic cord. METHODS: Review of cases reported in the literature. RESULTS: Testicular torsion rarely occurs in the perinatal period. Nearly a hundred cases with surgical confirmation have been reported. CONCLUSIONS: Prenatal torsion is almost exclusively extravaginal, while postnatal extravaginal torsion is extremely rare. The possibility of finding a viable testis is extremely remote. The treatment should be directed at minimizing any potential perioperative complications by scheduling an elective operation after the neonate is medically stable.
Assuntos
Torção do Cordão Espermático/congênito , Humanos , Recém-Nascido , Masculino , Torção do Cordão Espermático/diagnósticoRESUMO
OBJECTIVES: The present study reviewed the records of patients with Wilms' tumor treated at the University Hospital of Zaragoza from January, 1980 to January, 1995. METHODS: A retrospective study was conducted in 12 patients (5 boys and 7 girls) with Wilms' tumor, aged 9 months to 9.5 years, with special reference to the clinical symptoms and signs. RESULTS: In 9 of the 12 cases, the tumor was localized to the left kidney and 3 cases had right-sided involvement. No patient showed an unfavorable histological finding, intraoperative rupture or the associated phenotypic manifestations that are frequently described in cases with this tumor type. CONCLUSION: The mortality and survival rates are comparable with those reported by other authors in our country.