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1.
Trials ; 24(1): 528, 2023 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-37580782

RESUMO

BACKGROUND: Incisional hernia is a common complication after kidney transplantation with an incidence of 1.6-18%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after kidney transplantation with minimal risk for complication. METHODS/DESIGN: This is a blinded, randomized controlled trial comparing time to incisional hernia over a period of 24 months between patients undergoing kidney transplantation and standardized abdominal closure with or without prophylactic placement of ProGrip™ (Medtronic, Fridley, MN, USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial. DISCUSSION: The high risk for developing incisional hernia following kidney transplantation might be reduced by prophylactic mesh placement. ProGrip™ mesh features polylactic acid (PLA) microgrips that provide immediate, strong and uniform fixation. The use of this mesh combines the effectiveness demonstrated by the macropore propylene meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation that does not increase significantly surgery time, and safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02-18-2021).


Assuntos
Técnicas de Fechamento de Ferimentos Abdominais , Hérnia Incisional , Transplante de Rim , Humanos , Hérnia Incisional/diagnóstico , Hérnia Incisional/epidemiologia , Hérnia Incisional/etiologia , Transplante de Rim/efeitos adversos , Abdome , Laparotomia/efeitos adversos , Incidência , Telas Cirúrgicas/efeitos adversos , Técnicas de Fechamento de Ferimentos Abdominais/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Transl Androl Urol ; 11(12): 1637-1644, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36632162

RESUMO

Background: The coronavirus disease 2019 (COVID-19) pandemic has affected care for diseases like cancer. The aim was to evaluate the impact of COVID-19 on waiting times for diagnosis and treatment of prostate cancer (PC), as well as the possible effect on the treatment results in PC patients undergoing radical prostatectomy. Methods: We compared the results of 497 patients who underwent biopsy prior to the COVID-19 pandemic (1 January-31 December 2019) with those of 290 patients biopsied during the COVID-19 pandemic (1 January-31 December 2020). Demographic data, tumour characteristics, type of treatment and diagnosis times were comparable. Prostate specific antigen (PSA) levels were recorded at consultation prior to biopsy and after treatment. Mann-Whitney and chi-square tests were used to compare continuous variables and percentages, respectively. Results: In 2020, there were fewer urology consultations (35,160 vs. 40,225 in 2019). The median PSA in 2020 was significantly higher (14.3 vs. 9.9 ng/dL in 2019). In 2019, 53.1% (N=264) of the biopsies were positive for cancer vs. 47.2% (N=137) in 2020 (P=0.104). In 2020, more patients presented with metastatic disease (7.3% vs. 1.9%, P=0.009). Also, in 2020 there was a longer waiting time for prostate biopsy (42.1 vs. 35.3 days in 2019, P=0.019). A total of 132 patients underwent laparoscopic radical prostatectomy (LARP). The median time until surgery was similar in both years (71.9 vs. 58.29 days). During 2020, a higher percentage of patients had ISUP grade 4 in the surgical specimen (34.3% vs. 17.5%, P=0.07). Furthermore, a higher percentage of aggressive (pT3) tumours were diagnosed (37.2% vs. 27.2%, P=0.08), and the percentage of patients with involvement of surgical margins was also higher (48.6% vs. 29.3%, P=0.027). There were no differences between the groups in terms of biochemical recurrence or persistent PSA at one year (P=0.711). Conclusions: Delayed biopsy during the COVID-19 period did not appear to adversely impact biopsy results. Patients biopsied in 2020 had higher PSA, possibly due to proper triaging. A higher rate of adverse pathology outcomes was observed in patients undergoing radical prostatectomy during the pandemic, probably due to understaging of the biopsy. This study serves to raise awareness of the risk of deterioration of care of PC patients due to possible underdiagnosis.

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