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1.
Trials ; 25(1): 249, 2024 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-38594766

RESUMO

BACKGROUND: Malignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural Effusion (AMPLE)-4 trial is a multicentre randomised trial that evaluates the use of topical mupirocin prophylaxis (vs no mupirocin) to reduce catheter-related infections in patients with MPE treated with an IPC. METHODS: A pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants. DISCUSSION: Results from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections. ETHICS AND DISSEMINATION: Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.


Assuntos
Infecções Relacionadas a Cateter , Derrame Pleural Maligno , Humanos , Derrame Pleural Maligno/diagnóstico , Derrame Pleural Maligno/complicações , Qualidade de Vida , Mupirocina/efeitos adversos , Pleurodese/métodos , Talco/uso terapêutico , Cateteres de Demora/efeitos adversos , Infecções Relacionadas a Cateter/diagnóstico , Infecções Relacionadas a Cateter/prevenção & controle , Antibacterianos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
Intern Med J ; 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38560767

RESUMO

BACKGROUND: Malignant pleural effusions (MPEs) are common, and a third of them have underlying trapped lung (TL). Management of MPE and TL is suspected to be heterogeneous. Understanding current practices in Australasia is important in guiding policies and future research. AIMS: Electronic survey of Australia-New Zealand respiratory physicians, thoracic surgeons and their respective trainees to determine practice of MPE and TL management. RESULTS: Of the 132 respondents, 56% were respiratory physicians, 23% were surgeons and 20% were trainees. Many respondents defined TL as >25% or any level of incomplete lung expansion; 75% would use large-volume thoracentesis to determine whether TL was present. For patients with TL, indwelling pleural catheters (IPCs) were the preferred treatment irrespective of prognosis. In those without TL, surgical pleurodesis was the most common choice if prognosis was >6 months, whereas IPC was the preferred option if survival was <3 months. Only 5% of respondents considered decortication having a definite role in TL, but 55% would consider it in select cases. Forty-nine per cent of surgeons would not perform decortication when the lung does not fully expand intra-operatively. Perceived advantages of IPCs were minimisation of hospital time, effusion re-intervention and usefulness irrespective of TL status. Perceived disadvantages of IPCs were lack of suitable drainage care, potentially indefinite duration of catheter-in-situ and catheter complications. CONCLUSION: This survey highlights the lack of definition of TL and heterogeneity of MPE management in Australasia, especially for patients with expandable lungs. This survey also identified the main hurdles of IPC use that should be targeted.

4.
J Obstet Gynaecol Res ; 49(4): 1230-1243, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36726190

RESUMO

BACKGROUND: Despite the introduction of cervical cancer screening and human papillomavirus (HPV) vaccines, the utilization pattern was not standardized. The aim of this study was to elicit the current prevention care in Asia-Oceania. METHODS: An online questionnaire was circulated to different countries/cities in Asia-Oceania. The primary objective was to evaluate the coverage of HPV vaccination and cervical screening programs. The secondary objectives were to study the structures of these programs. Five case scenarios were set to understand how the respondents manage the abnormal screening results. RESULTS: Fourteen respondents from 10 countries/cities had participated. Cervical cancer ranked the first in Myanmar and Nepal. About 10%-15% did not have national vaccination or screening program. The estimated coverage rate for vaccination and screening varied from less than 1% to 70%, which the coverage ran in parallel with the incidence and mortality rates of cervical cancer. All regions approved HPV vaccines, although only four provided free or subsidized programs for nonavalent vaccine. Cervical cytology remained the most common screening tool, and 20%-30% relied heavily on visual inspection using acetic acid. The screening age groups varied in different regions. From the case scenarios, it was noted that some respondents tended to offer more frequent screening tests or colposcopy than recommended by international guidelines. CONCLUSION: This study revealed discrepancy in the practice of cervical cancer prevention in Asia-Oceania especially access to HPV vaccines. There is an urgent need for a global collaboration to eliminate cervical cancer by public education, reforming services, and medical training.


Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Neoplasias do Colo do Útero , Feminino , Humanos , Ásia/epidemiologia , Detecção Precoce de Câncer/métodos , Programas de Rastreamento , Oceania , Infecções por Papillomavirus/complicações , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/prevenção & controle , Disparidades em Assistência à Saúde
5.
Med Mycol Case Rep ; 39: 23-25, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36632528

RESUMO

We report a case of intractable Aspergillus otomycosis with multiple relapses despite conventional topical and systemic antifungal treatment, and adjunctive usage of hyperbaric oxygen therapy. Of note, otomycosis relapsed even after six months of continuous systemic antifungal treatment with therapeutic drug levels and without treatment interruption; and only resolved after application of topical voriconazole. (max. 75 words).

6.
ACS Omega ; 7(26): 22089-22110, 2022 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-35811905

RESUMO

Visible-light-responsive photocatalytic materials have a multitude of important applications, ranging from energy conversion and storage to industrial waste treatment. Molybdenum disulfide (MoS2) and its variants exhibit high photocatalytic activity under irradiation by visible light as well as good stability and recyclability, which are desirable for all photocatalytic applications. MoS2-based materials have been widely applied in various fields such as wastewater treatment, environmental remediation, and organic transformation reactions because of their excellent physicochemical properties. The present review focuses on the fundamental properties of MoS2, recent developments and remaining challenges, and key strategies for tackling issues related to the utilization of MoS2 in photocatalysis. The application of MoS2-based materials in visible-light-induced catalytic reactions for the treatment of diverse kinds of pollutants including industrial, environmental, pharmaceutical, and agricultural waste are also critically discussed. The review concludes by highlighting the prospects of MoS2 for use in various established and emerging areas of photocatalysis.

7.
Trials ; 23(1): 530, 2022 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-35761341

RESUMO

INTRODUCTION: Malignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery. METHODS AND ANALYSIS: A multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months and good performance status randomised 1:1 to either IPC or VATS pleurodesis. Participant randomisation will be minimised for (i) cancer type (mesothelioma vs non-mesothelioma); (ii) previous pleurodesis (vs not); and (iii) trapped lung, if known (vs not). Primary outcome is the need for further ipsilateral pleural interventions over 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months. ETHICS AND DISSEMINATION: Sir Charles Gairdner and Osborne Park Health Care Group (HREC) has approved the study (reference: RGS356). Results will be published in peer-reviewed journals and presented at scientific meetings. DISCUSSION: Both IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12618001013257 . Registered on 18 June 2018. PROTOCOL VERSION: Version 3.00/4.02.19.


Assuntos
Derrame Pleural Maligno , Cateteres de Demora/efeitos adversos , Drenagem/métodos , Humanos , Estudos Multicêntricos como Assunto , Derrame Pleural Maligno/complicações , Derrame Pleural Maligno/terapia , Pleurodese/efeitos adversos , Pleurodese/métodos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Talco , Cirurgia Torácica Vídeoassistida/efeitos adversos
10.
Am J Respir Crit Care Med ; 205(9): 1093-1101, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35081010

RESUMO

Rationale: Pleural effusion commonly complicates community-acquired pneumonia and is associated with intense pleural inflammation. Whether antiinflammatory treatment with corticosteroids improves outcomes is unknown. Objectives: To assess the effects of corticosteroids in an adult population with pneumonia-related pleural effusion. Methods: The STOPPE (Steroid Therapy and Outcome of Parapneumonic Pleural Effusions) trial was a pilot, multicenter, double-blinded, placebo-controlled, randomized trial involving six Australian centers. Patients with community-acquired pneumonia and pleural effusion were randomized (2:1) to intravenous dexamethasone (4 mg twice daily for 48 h) or placebo and followed for 30 days. Given the diverse effects of corticosteroids, a comprehensive range of clinical, serological, and imaging outcomes were assessed in this pilot trial (ACTRN12618000947202). Measurements and Main Results: Eighty patients were randomized (one withdrawn before treatment) and received dexamethasone (n = 51) or placebo (n = 28). This pilot trial found no preliminary evidence of benefits of dexamethasone in improving time to sustained (>12 h) normalization of vital signs (temperature, oxygen saturations, blood pressure, heart, and respiratory rates): median, 41.0 (95% confidence interval, 32.3-54.5) versus 27.8 (15.4-49.5) hours in the placebo arm (hazard ratio, 0.729 [95% confidence interval, 0.453-1.173]; P = 0.193). Similarly, no differences in C-reactive protein or leukocyte counts were observed, except for a higher leukocyte count in the dexamethasone group at Day 3. Pleural drainage procedures were performed in 49.0% of dexamethasone-treated and 42.9% of placebo-treated patients (P = 0.60). Radiographic pleural opacification decreased over time with no consistent intergroup differences. Mean duration of antibiotic therapy (22.4 [SD, 15.4] vs. 20.4 [SD, 13.8] d) and median hospitalization (6.0 [interquartile range, 5.0-10.0] vs. 5.5 [interquartile range, 5.0-8.0] d) were similar between the dexamethasone and placebo groups. Serious adverse events occurred in 25.5% of dexamethasone-treated and 21.4% of placebo-treated patients. Transient hyperglycemia more commonly affected the dexamethasone group (15.6% vs. 7.1%). Conclusions: Systemic corticosteroids showed no preliminary benefits in adults with parapneumonic effusions. Clinical trial registered with www.anzctr.org.au (ACTRN12618000947202).


Assuntos
Infecções Comunitárias Adquiridas , Derrame Pleural , Pneumonia , Corticosteroides/uso terapêutico , Adulto , Austrália , Infecções Comunitárias Adquiridas/complicações , Infecções Comunitárias Adquiridas/tratamento farmacológico , Dexametasona/uso terapêutico , Humanos , Projetos Piloto , Derrame Pleural/tratamento farmacológico , Pneumonia/complicações , Esteroides/uso terapêutico
11.
Bioprocess Biosyst Eng ; 45(2): 279-295, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34727229

RESUMO

Synthesized cerium oxide nanoparticles (S-CeO2 NPs) and 1%, 5% and 10% zirconium doped CeO2 (Zr-doped CeO2) NPs were fabricated using aqueous leaf extract of Pometia pinnata. The synthesized NPs were characterized using standard techniques which confirmed successful synthesis of NPs with particle size ranging from 12 to 23 nm and band gap energy of 2.54-2.66 eV. Photoantioxidant activities showed enhanced activities under visible light irradiation in comparison to the dark condition in the dose-dependent study. Biofilm inhibition studies showed ~ 73% biofilm inhibition of Staphylococcus aureus at 512 µg/mL for S-CeO2, whereas 10% Zr-doped CeO2 NPs showed biofilm inhibition of 52.7%. The bactericidal tests showed killing properties at 1024 µg/mL of S-CeO2 NPs and at 512 µg/mL of 1% Zr-doped CeO2. Reduced bactericidal activities were observed for 5% and 10% Zr-doped CeO2. These studies showed that the fabricated NPs have both good photoantioxidant and antibacterial properties.


Assuntos
Cério , Nanopartículas Metálicas , Nanopartículas , Antibacterianos/farmacologia , Biofilmes , Cério/farmacologia , Tamanho da Partícula , Extratos Vegetais/farmacologia , Staphylococcus aureus
12.
Open Forum Infect Dis ; 8(12): ofab516, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34909437

RESUMO

Candida endophthalmitis is a serious complication of candidemia. Diagnosis requires identification of ocular lesions on dilated fundoscopy, aided by isolation of the organism from blood and/or vitreous humor. However, the initial ophthalmological examination may be negative in some cases. Experience with isavuconazole for the treatment of Candida endophthalmitis is limited. We present a case of a 65-year-old woman with metastatic breast cancer on chemotherapy who developed Candida dubliniensis endophthalmitis with initial negative ophthalmological examination. She was treated with vitrectomy and 6 weeks of oral fluconazole. Despite vitrectomy and culture-directed antifungal treatment, management was complicated by lack of response to fluconazole and intolerance to other antifungals, necessitating the use of isavuconazole, which proved efficacious.

14.
J Mater Chem B ; 9(28): 5599-5620, 2021 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-34161404

RESUMO

Cerium oxide nanoparticles (CeO2 NPs) are a sought-after material in numerous fields due to their potential applications such as in catalysis, cancer therapy, photocatalytic degradation of pollutants, sensors, polishing agents. Green synthesis usually involves the production of CeO2 assisted by organic extracts obtained from plants, leaves, flowers, bacteria, algae, food, fruits, etc. The phytochemicals present in the organic extracts adhere to the NPs and act as reducing and/or oxidizing agents and capping agents to stabilize the NPs, modify the particle size, morphology and band gap energy of the as-synthesized materials, which would be advantageous for numerous applications. This review focuses on the green extract-mediated synthesis of CeO2 NPs and discusses the effects on CeO2 NPs of various synthesis methods that have been reported. Several photocatalytic, antimicrobial, antioxidant and cytotoxicity applications have been evaluated, compared and discussed. Future prospects are also suggested.


Assuntos
Anti-Infecciosos/farmacologia , Antineoplásicos Fitogênicos/farmacologia , Antioxidantes/farmacologia , Cério/farmacologia , Compostos Fitoquímicos/farmacologia , Extratos Vegetais/farmacologia , Anti-Infecciosos/química , Anti-Infecciosos/isolamento & purificação , Antineoplásicos Fitogênicos/química , Antineoplásicos Fitogênicos/isolamento & purificação , Antioxidantes/química , Antioxidantes/isolamento & purificação , Catálise , Cério/química , Cério/isolamento & purificação , Química Verde , Humanos , Nanopartículas/química , Processos Fotoquímicos , Compostos Fitoquímicos/química , Compostos Fitoquímicos/isolamento & purificação , Extratos Vegetais/química , Extratos Vegetais/isolamento & purificação
15.
Biomater Sci ; 9(14): 4854-4869, 2021 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-33908451

RESUMO

Cerium oxide (CeO2) and 1%, 5% and 10% zirconium/tin-dual doped CeO2 nanoparticles (Zr/Sn-dual doped CeO2 NPs) were synthesized using an aqueous leaf extract of Pometia pinnata. By using UV-visible diffuse reflectance spectroscopy, the band gap energies of these materials were found to be in the range of ∼2.49 to 2.66 eV. The average crystallite sizes of the fluorite phase obtained from X-ray diffraction were between 7 and 16 nm. X-ray photoelectron spectroscopy (XPS) analysis further confirmed the synthesis of CeO2 and Sn-doped CeO2 NPs. Almost spherical shapes of the nanomaterials with an average particle size of 12-17 nm were determined using scanning electron microscopy and transmission electron microscopy studies. Photoantioxidant activities of the synthesized materials showed enhanced photoantioxidant response under visible light irradiation in comparison with those under dark conditions in both dose- and time-dependent manner. The CeO2 NPs exhibited a significant concentration-dependent antibiofilm activity against the Gram-positive bacteria Staphylococcus aureus (S. aureus) and Listeria monocytogenes (L. monocytogenes). Only the 10% Zr/Sn-dual doped-CeO2 NPs were found to inhibit S. aureus biofilm formation at higher concentrations. All Zr/Sn-dual doped CeO2 NPs exhibited a concentration-dependent biofilm inhibition of L. monocytogenes and also bactericidal activity towards S. aureus. These nanomaterials exhibited enhanced photoantioxidant activities and antibacterial properties, which make them suitable for various biological applications.


Assuntos
Nanopartículas , Staphylococcus aureus , Antibacterianos/farmacologia , Biofilmes , Tamanho da Partícula , Extratos Vegetais , Difração de Raios X
16.
J Obstet Gynaecol Res ; 47(5): 1643-1650, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33650217

RESUMO

Since the outbreak of COVID-19, there have already been over 26 million people being infected and it is expected that the pandemic will not end in near future. Not only the daily activities and lifestyles of individuals have been affected, the medical practice has also been modified to cope with this emergency catastrophe. In particular, the cancer services have faced an unprecedented challenge. While the services may have been cut by the national authorities or hospitals due to shortage of manpower and resources, the medical need of cancer patients has increased. Cancer patients who are receiving active treatment may develop various kinds of complications especially immunosuppression from chemotherapy, and they and their carers will need additional protection against COVID-19. Besides, there is also evidence that cancer patients are more prone to deteriorate from COVID-19 if they contract the viral infection. Therefore, it is crucial to establish guidelines so that healthcare providers can triage their resources to take care of the most needed patients, reduce less important hospitalization and visit, and to avoid potential complications from treatment. The Asia and Oceania Federation of Obstetrics and Gynecology (AOFOG) hereby issued this opinion statement on the management of gynecological cancer patients during the COVID-19.


Assuntos
COVID-19 , Neoplasias dos Genitais Femininos , Ginecologia , Obstetrícia , Ásia/epidemiologia , Feminino , Neoplasias dos Genitais Femininos/epidemiologia , Neoplasias dos Genitais Femininos/terapia , Humanos , Oceania , Gravidez , SARS-CoV-2
17.
Bioprocess Biosyst Eng ; 44(7): 1333-1372, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33661388

RESUMO

Zinc oxide nanoparticles (ZnO NPs) are considered as very significant and essential material due to its multifunctional properties, stability, low cost and wide usage. Many green and biogenic approaches for ZnO NPs synthesis have been reported using various sources such as plants and microorganisms. Plants contain biomolecules that can act as capping, oxidizing and reducing agents that increase the rate of reaction and stabilizes the NPs. This review emphasizes and compiles different types of plants and parts of plant used for the synthesis of ZnO and its potential applications at one place. The influence of biogenic and phytogenic synthesized ZnO on its properties and possible mechanisms for its fabrication has been discussed. This review also highlights the potential applications and future prospects of phytogenic synthesized ZnO in the field of energy production and storage, sun light harvesting, environmental remediation, and biological applications.


Assuntos
Biocombustíveis , Hidrogênio/química , Nanopartículas Metálicas/química , Testes de Sensibilidade Microbiana , Nanoestruturas/química , Óxido de Zinco/química , Animais , Antibacterianos , Catálise , Linhagem Celular Tumoral , Avaliação Pré-Clínica de Medicamentos , Recuperação e Remediação Ambiental , Desenho de Equipamento , Química Verde , Humanos , Compostos Fitoquímicos/química , Extratos Vegetais , Pós , Espectrofotometria Ultravioleta , Temperatura , Difração de Raios X
18.
Med Mycol Case Rep ; 32: 47-49, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33786294

RESUMO

Candida infections of the central nervous system (CNS) are rare. We report a case of Candida glabrata meningitis successfully treated with combination antifungal therapy followed by step-down therapy with fluconazole. New-onset hypercalcaemia, an uncommon side effect of the prolonged fluconazole treatment, prompted early treatment cessation. A negative cerebrospinal fluid (CSF) ß-d-glucan supported the decision of treatment cessation despite incomplete resolution of CSF biochemical parameters. No disease relapse was encountered after 2 years post-treatment.

19.
Bioprocess Biosyst Eng ; 44(4): 875-889, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33527232

RESUMO

Aqueous leaf extract of Ziziphus mauritiana Lam. was successfully used to synthesize zinc oxide (ZnO) and magnesium-doped ZnO (Mg-doped ZnO) particles and acted as capping and stabilizing agent. UV-Vis diffuse reflectance spectra showed that optical band gap energy of ZnO has narrowed from 3.11 to 3.08 eV and 3.03 eV when doped with 1% Mg and 5% Mg, respectively. Powder X-ray diffraction and X-ray photoelectron spectroscopy studies confirmed the purity and crystalline nature of the synthesized materials. FT-IR spectroscopy revealed the presence of phytochemicals coated on the surface of synthesized materials. The synthesized materials were found to effectively scavenge DPPH radicals in the presence of visible light in comparison to the dark. The antibacterial properties of the synthesized materials were evaluated against Staphylococcus aureus and Escherichia coli. The obtained results revealed that Staphylococcus aureus seemed to be more sensitive to the green synthesized ZnO and Mg-doped ZnO than Escherichia coli.


Assuntos
Antibacterianos/química , Antioxidantes/química , Magnésio/química , Extratos Vegetais/análise , Folhas de Planta/metabolismo , Óxido de Zinco/química , Ziziphus/metabolismo , Ácido Ascórbico/química , Escherichia coli/metabolismo , Química Verde , Microscopia Eletrônica de Varredura , Compostos Fitoquímicos , Espectrofotometria Ultravioleta , Espectroscopia de Infravermelho com Transformada de Fourier , Staphylococcus aureus/metabolismo , Difração de Raios X
20.
Gynecol Oncol ; 159(3): 623-629, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33032824

RESUMO

OBJECTIVE: Adenocarcinoma in situ (AIS) of the cervix is a precursor to cervical adenocarcinoma. When AIS is detected by cervical screening an excision biopsy is mandatory to exclude invasion. We aimed to compare margins status, specimen size and fragmentation after loop electrosurgical excision procedure (LEEP) and 'cold knife cone biopsy' (CKC). METHODS: The EXCISE Trial was an investigator-initiated, multicenter, open-label, parallel-group, phase 2, randomized study. Patients were enrolled at seven hospitals in Australia and New Zealand. We randomly assigned women aged ≥18 to ≤45 years with screen detected AIS to LEEP or CKC. Co-primary endpoints were margin status, specimen size and fragmentation. Analysis was by intention-to-treat. RESULTS: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. Margin status was evaluable in 36 cases. The proportion of patients with involved margins did not differ between groups. 25 of 26 LEEP and all 14 CKC biopsies were excised as single specimens (p = 1·00). There were no differences in specimen dimensions. Patients in the CKC group had more post-operative complications (64.3% compared to 15.4% for LEEP p = ·00). There were no differences in grade three complications (p = ·65). CONCLUSIONS: LEEP was not associated with a greater likelihood of positive margins, specimen fragmentation or smaller excision compared to CKC when performed according to a standardized protocol. However, the study was not powered to establish non-inferiority of LEEP and a definitive phase 3 trial to compare margin status and rates of treatment failure after LEEP and CKC is warranted.


Assuntos
Adenocarcinoma in Situ/cirurgia , Eletrocirurgia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Neoplasias do Colo do Útero/cirurgia , Adenocarcinoma in Situ/patologia , Adulto , Biópsia/efeitos adversos , Biópsia/instrumentação , Biópsia/métodos , Colo do Útero/patologia , Colo do Útero/cirurgia , Eletrocirurgia/instrumentação , Eletrocirurgia/métodos , Feminino , Humanos , Margens de Excisão , Projetos Piloto , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Índice de Gravidade de Doença , Neoplasias do Colo do Útero/patologia
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