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A randomized trial comparing limited-excision conisation to Large Loop Excision of the Transformation Zone (LLETZ) in cervical dysplasia patients.
Kolben, Theresa Maria; Etzel, Lea T; Bergauer, Florian; Hagemann, Ingke; Hillemanns, Peter; Repper, Monika; Kaufmann, Andreas M; Sotlar, Karl; Kolben, Thomas; Helms, Hans Joachim; Gallwas, Julia; Mahner, Sven; Dannecker, Christian.
Afiliação
  • Kolben TM; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany. Theresa.Kolben@med.uni-muenchen.de.
  • Etzel LT; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany.
  • Bergauer F; Amedes MVZ for Gynecology and Pathology Munich GmbH, Munich, Germany.
  • Hagemann I; Dysplasie Einheit abts+partner, Kiel, Germany.
  • Hillemanns P; Department of Obstetrics and Gynaecology, Hannover Medical School, Hannover, Germany.
  • Repper M; Department of Obstetrics and Gynaecology, Hannover Medical School, Hannover, Germany.
  • Kaufmann AM; Department for Gynecology, Charité-Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
  • Sotlar K; Institute of Pathology, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.
  • Kolben T; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany.
  • Helms HJ; Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany.
  • Gallwas J; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany.
  • Mahner S; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany.
  • Dannecker C; Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany.
J Gynecol Oncol ; 30(3): e42, 2019 May.
Article em En | MEDLINE | ID: mdl-30887760
ABSTRACT

OBJECTIVE:

To show noninferiority of a limited-excision (resection of the dysplastic lesion only) vs. classical Large Loop Excision of the Transformation Zone (LLETZ).

METHODS:

In this prospective, randomized, multicenter trial, women with human papillomavirus (HPV) positive cervical intraepithelial neoplasia grade 3 were randomized into two groups (11). Primary outcome was the rate of negative HPV tests after 6 months, secondary outcomes included cone size, complete resection rates as well as cytological and histological results after 6 and 12 months. A sample size of 1,000 was calculated to show noninferiority of the limited-excision compared to the LLETZ group using a noninferiority margin of 5%. Enrollment was stopped after 100 patients due to slow accrual.

RESULTS:

Patients in the limited-excision group did not show a lower number of negative HPV tests (78% [LLETZ]-80% [limited-excision]=-2%; 90% confidence interval=-15%, 12%). The limited-excision resulted in a substantially lower cone size (LLETZ 1.97 mL vs. limited-excision 1.02 mL; p<0.001) but higher numbers of involved margins (LLETZ 8% vs. limited-excision 20%). Although postoperative cytological results slightly differed, histological results were similar in both groups. One limited-excision patient received immediate re-conisation, whereas one patient in each group was scheduled for re-conisation after 6 months.

CONCLUSION:

The limited-excision could represent a promising option to reduce the surgical extent of conisations while maintaining oncological safety. The trial was not sufficiently powered to reach statistical significance due to early termination. Nevertheless, the study provides important insights in the feasibility of a limited-excision and could serve as a pilot study for future trials. TRIAL REGISTRATION German Clinical Trials Register Identifier DRKS00006169.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transformação Celular Viral / Displasia do Colo do Útero / Neoplasias do Colo do Útero / Colo do Útero / Infecções por Papillomavirus / Margens de Excisão Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Middle aged País/Região como assunto: Europa Idioma: En Revista: J Gynecol Oncol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transformação Celular Viral / Displasia do Colo do Útero / Neoplasias do Colo do Útero / Colo do Útero / Infecções por Papillomavirus / Margens de Excisão Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Middle aged País/Região como assunto: Europa Idioma: En Revista: J Gynecol Oncol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Alemanha