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Paul A Cohen - One of the best experts on this subject based on the ideXlab platform.

  • ex cisional treatment c omparison for i n s itu e ndocervical adenocarcinoma excise a phase 2 pilot randomised controlled trial to compare histopathological margins status Specimen Size and fragmentation after loop electrosurgical excision procedure
    Social Science Research Network, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand, Max Bulsara
    Abstract:

    Background: 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. Two common procedures are loop electrosurgical excision procedure (LEEP) and ‘cold knife cone biopsy’ (CKC), yet no randomised trials have compared these modalities. We aimed to compare margins status, Specimen Size and fragmentation after LEEP and CKC. Methods: The EXCISE Trial was an investigator-initiated, multicentre, open-label, parallel-group, phase 2, randomised 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 by computer generated random numbers. Co-primary endpoints were margin status, Specimen Size and fragmentation. Analysis was by intention-to-treat. Findings: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. All patients were included in the analysis. 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). Interpretation: LEEP was not associated with a greater likelihood of positive margins, Specimen fragmentation or smaller excision compared to CKC when performed according to a standardised 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. Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR registration number ACTRN12617000132347). Funding Statement: Australia New Zealand Gynaecological Oncology Group [#FNR2016/03]. Declaration of Interests: PAC and CDHW have received honoraria from Seqirus unrelated to this work. All other authors declare no competing interests. Ethics Approval Statement: Ethical approval for the study was granted by the St John of God Healthcare Human Research Ethics Committee (Reference number #1137) and approvals were obtained at all participating sites.

  • excisional treatment comparison for in situ endocervical adenocarcinoma excise a phase 2 pilot randomized controlled trial to compare histopathological margin status Specimen Size and fragmentation after loop electrosurgical excision procedure and co
    Gynecologic Oncology, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand
    Abstract:

    Abstract 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.

Alison Brand - One of the best experts on this subject based on the ideXlab platform.

  • ex cisional treatment c omparison for i n s itu e ndocervical adenocarcinoma excise a phase 2 pilot randomised controlled trial to compare histopathological margins status Specimen Size and fragmentation after loop electrosurgical excision procedure
    Social Science Research Network, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand, Max Bulsara
    Abstract:

    Background: 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. Two common procedures are loop electrosurgical excision procedure (LEEP) and ‘cold knife cone biopsy’ (CKC), yet no randomised trials have compared these modalities. We aimed to compare margins status, Specimen Size and fragmentation after LEEP and CKC. Methods: The EXCISE Trial was an investigator-initiated, multicentre, open-label, parallel-group, phase 2, randomised 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 by computer generated random numbers. Co-primary endpoints were margin status, Specimen Size and fragmentation. Analysis was by intention-to-treat. Findings: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. All patients were included in the analysis. 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). Interpretation: LEEP was not associated with a greater likelihood of positive margins, Specimen fragmentation or smaller excision compared to CKC when performed according to a standardised 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. Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR registration number ACTRN12617000132347). Funding Statement: Australia New Zealand Gynaecological Oncology Group [#FNR2016/03]. Declaration of Interests: PAC and CDHW have received honoraria from Seqirus unrelated to this work. All other authors declare no competing interests. Ethics Approval Statement: Ethical approval for the study was granted by the St John of God Healthcare Human Research Ethics Committee (Reference number #1137) and approvals were obtained at all participating sites.

  • excisional treatment comparison for in situ endocervical adenocarcinoma excise a phase 2 pilot randomized controlled trial to compare histopathological margin status Specimen Size and fragmentation after loop electrosurgical excision procedure and co
    Gynecologic Oncology, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand
    Abstract:

    Abstract 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.

Yee Leung - One of the best experts on this subject based on the ideXlab platform.

  • ex cisional treatment c omparison for i n s itu e ndocervical adenocarcinoma excise a phase 2 pilot randomised controlled trial to compare histopathological margins status Specimen Size and fragmentation after loop electrosurgical excision procedure
    Social Science Research Network, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand, Max Bulsara
    Abstract:

    Background: 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. Two common procedures are loop electrosurgical excision procedure (LEEP) and ‘cold knife cone biopsy’ (CKC), yet no randomised trials have compared these modalities. We aimed to compare margins status, Specimen Size and fragmentation after LEEP and CKC. Methods: The EXCISE Trial was an investigator-initiated, multicentre, open-label, parallel-group, phase 2, randomised 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 by computer generated random numbers. Co-primary endpoints were margin status, Specimen Size and fragmentation. Analysis was by intention-to-treat. Findings: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. All patients were included in the analysis. 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). Interpretation: LEEP was not associated with a greater likelihood of positive margins, Specimen fragmentation or smaller excision compared to CKC when performed according to a standardised 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. Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR registration number ACTRN12617000132347). Funding Statement: Australia New Zealand Gynaecological Oncology Group [#FNR2016/03]. Declaration of Interests: PAC and CDHW have received honoraria from Seqirus unrelated to this work. All other authors declare no competing interests. Ethics Approval Statement: Ethical approval for the study was granted by the St John of God Healthcare Human Research Ethics Committee (Reference number #1137) and approvals were obtained at all participating sites.

  • excisional treatment comparison for in situ endocervical adenocarcinoma excise a phase 2 pilot randomized controlled trial to compare histopathological margin status Specimen Size and fragmentation after loop electrosurgical excision procedure and co
    Gynecologic Oncology, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand
    Abstract:

    Abstract 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.

Paola Chivers - One of the best experts on this subject based on the ideXlab platform.

  • ex cisional treatment c omparison for i n s itu e ndocervical adenocarcinoma excise a phase 2 pilot randomised controlled trial to compare histopathological margins status Specimen Size and fragmentation after loop electrosurgical excision procedure
    Social Science Research Network, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand, Max Bulsara
    Abstract:

    Background: 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. Two common procedures are loop electrosurgical excision procedure (LEEP) and ‘cold knife cone biopsy’ (CKC), yet no randomised trials have compared these modalities. We aimed to compare margins status, Specimen Size and fragmentation after LEEP and CKC. Methods: The EXCISE Trial was an investigator-initiated, multicentre, open-label, parallel-group, phase 2, randomised 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 by computer generated random numbers. Co-primary endpoints were margin status, Specimen Size and fragmentation. Analysis was by intention-to-treat. Findings: Between August 2, 2017 and September 6, 2019, 40 patients were randomly assigned 2:1 to LEEP or CKC. All patients were included in the analysis. 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). Interpretation: LEEP was not associated with a greater likelihood of positive margins, Specimen fragmentation or smaller excision compared to CKC when performed according to a standardised 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. Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR registration number ACTRN12617000132347). Funding Statement: Australia New Zealand Gynaecological Oncology Group [#FNR2016/03]. Declaration of Interests: PAC and CDHW have received honoraria from Seqirus unrelated to this work. All other authors declare no competing interests. Ethics Approval Statement: Ethical approval for the study was granted by the St John of God Healthcare Human Research Ethics Committee (Reference number #1137) and approvals were obtained at all participating sites.

  • excisional treatment comparison for in situ endocervical adenocarcinoma excise a phase 2 pilot randomized controlled trial to compare histopathological margin status Specimen Size and fragmentation after loop electrosurgical excision procedure and co
    Gynecologic Oncology, 2020
    Co-Authors: Paul A Cohen, Yee Leung, Lyndal Anderson, Rachael Van Der Griend, Paola Chivers, Sanela Bilic, Sophie Bittinger, Alison Brand
    Abstract:

    Abstract 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.

Michael R Wisnom - One of the best experts on this subject based on the ideXlab platform.

  • reduction in tensile and flexural strength of unidirectional glass fibre epoxy with increasing Specimen Size
    Composite Structures, 1997
    Co-Authors: Michael R Wisnom, J W Atkinson
    Abstract:

    Abstract Size effects in tensile failure were investigated by means of tensile and four-point bending tests. Tapered tensile Specimens with plies dropped off internally showed a reduction in strain at failure with increasing gauge length. Scaled bending tests also showed a reduction in strain with increasing Specimen Size. These two effects and the relationship between the tensile and flexural results could all be fitted satisfactorily with a Weibull strength model.

  • reduction in compressive strain to failure with increasing Specimen Size in pin ended buckling tests
    Composites Science and Technology, 1997
    Co-Authors: Michael R Wisnom, J W Atkinson, Mike I Jones
    Abstract:

    Flexural tests were performed on unidirectional T800/924 carbon-fibre/epoxy composites in a pin-ended buckling rig producing consistent compressive failures. Three sets of tests were carried out with all dimensions geometrically scaled. The results showed a strong decrease in strain at failure with increasing Specimen Size. Three further sets of tests were conducted where the thickness was kept constant and the length and width of the Specimens varied. These showed similar strains at failure, suggesting that the Size effect observed with the scaled Specimens is predominantly due to the reduction in strain gradient with increasing Specimen thickness.

  • effect of Specimen Size on interlaminar shear strength of unidirectional carbon fibre epoxy
    Composites Engineering, 1994
    Co-Authors: Michael R Wisnom, Michael R. Jones
    Abstract:

    Abstract A systematic study has been undertaken to investigate the effect of Specimen Size on the interlaminar shear strength of unidirectional carbon fibre-epoxy using the three-point short-beam shear test. By varying the test parameters such as the ratio of span to thickness and the diameter of the loading roller, it is found that a valid interlaminar shear failure mode can be obtained and thus the three-point short-beam shear test can be used as a reliable method to measure the interlaminar shear strength, at least on a comparitive basis. From tests on four sets of scaled Specimens, a significant Size effect is found in the interlaminar shear strength. However, the Weibull statistical model does not satisfactorily represent the Size effect. The test results indicate that the Weibull modulus increases with decreasing Size, and suggest that the strength is approaching a limiting value for small Specimens.

  • the effect of Specimen Size on the bending strength of unidirectional carbon fibre epoxy
    Composite Structures, 1991
    Co-Authors: Michael R Wisnom
    Abstract:

    Four-point bending and pinned-end buckling tests were carried out on scaled Specimens of 25, 50 and 100 plies. Both types of test gave similar results and showed a significant decrease in strength with increasing Specimen Size. The smaller Specimens tended to fail progressively in tension. The tensile strain to failure decreased by about 8% for each doubling of Specimen Size. This corresponds to a Weibull modulus of about 25. However the amount of scatter in the results was much smaller than that expected based on Weibull strength theory. The larger Specimens tended to fail catastrophically in compression. This suggests a reduction in compressive strength with Specimen Size which may be even larger than the reduction in tensile strength.