OBJECTIVE: To compare two electrosurgical techniques, straight-wire excision of transformation zone (SWETZ) with large loop excision of transformation zone, as a cone procedure (LLETZ-cone), for the treatment of cervical intraepithelial neoplasia (CIN), when disease is present at the cervical canal. DESIGN: Randomised controlled trial. SETTING: Two public hospitals, one in Rio de Janeiro, Brazil and one in Dublin, Ireland. POPULATION: One hundred and three women with indication to treat CIN located at cervical canal. METHODS: Women were randomised to receive LLETZ-cone or SWETZ. OUTCOMES: Main outcome was the incidence of complete excision of disease at endocervical margin of the surgical specimen. Secondary outcomes were complete excision at ectocervical and stromal margins, time to complete the procedure, specimen fragmentation, blood loss and death after 1 year. RESULTS:Fifty-two women were allocated to LLETZ-cone and 51 to SWETZ. Ten women were lost for main outcome because of damaged specimens. Forty-two women in the LLETZ-cone group had free endocervical margin versus 43 women in the SWETZ group (relative risk 1.04, 95% confidence interval [95% CI] 0.87-1.25; P = 0.64). For secondary outcomes related to margins, we observed a relative risk of 1.15 (95% CI 0.95-1.39; P = 0.15) for ectocervical free margin. For free stromal margin, the relative risk was 1.07 (95% CI 0.89-1.29; P = 0.47). No death was observed. CONCLUSIONS: This study was inconclusive; SWETZ and LLETZ-cone were equally effective to treat endocervical disease, with no difference in protecting against margin involvement. Higher, but not severe, blood loss and longer surgical time were observed in the SWETZ group.
RCT Entities:
OBJECTIVE: To compare two electrosurgical techniques, straight-wire excision of transformation zone (SWETZ) with large loop excision of transformation zone, as a cone procedure (LLETZ-cone), for the treatment of cervical intraepithelial neoplasia (CIN), when disease is present at the cervical canal. DESIGN: Randomised controlled trial. SETTING: Two public hospitals, one in Rio de Janeiro, Brazil and one in Dublin, Ireland. POPULATION: One hundred and three women with indication to treat CIN located at cervical canal. METHODS:Women were randomised to receive LLETZ-cone or SWETZ. OUTCOMES: Main outcome was the incidence of complete excision of disease at endocervical margin of the surgical specimen. Secondary outcomes were complete excision at ectocervical and stromal margins, time to complete the procedure, specimen fragmentation, blood loss and death after 1 year. RESULTS: Fifty-two women were allocated to LLETZ-cone and 51 to SWETZ. Ten women were lost for main outcome because of damaged specimens. Forty-two women in the LLETZ-cone group had free endocervical margin versus 43 women in the SWETZ group (relative risk 1.04, 95% confidence interval [95% CI] 0.87-1.25; P = 0.64). For secondary outcomes related to margins, we observed a relative risk of 1.15 (95% CI 0.95-1.39; P = 0.15) for ectocervical free margin. For free stromal margin, the relative risk was 1.07 (95% CI 0.89-1.29; P = 0.47). No death was observed. CONCLUSIONS: This study was inconclusive; SWETZ and LLETZ-cone were equally effective to treat endocervical disease, with no difference in protecting against margin involvement. Higher, but not severe, blood loss and longer surgical time were observed in the SWETZ group.
Authors: Giorgio Bogani; Luca Lalli; Francesco Sopracordevole; Andrea Ciavattini; Alessandro Ghelardi; Tommaso Simoncini; Francesco Plotti; Jvan Casarin; Maurizio Serati; Ciro Pinelli; Alice Bergamini; Barbara Gardella; Andrea Dell'Acqua; Ermelinda Monti; Paolo Vercellini; Innocenza Palaia; Giorgia Perniola; Margherita Fischetti; Giusi Santangelo; Alice Fracassi; Giovanni D'Ippolito; Lorenzo Aguzzoli; Vincenzo Dario Mandato; Luca Giannella; Cono Scaffa; Francesca Falcone; Chiara Borghi; Mario Malzoni; Andrea Giannini; Maria Giovanna Salerno; Viola Liberale; Biagio Contino; Cristina Donfrancesco; Michele Desiato; Anna Myriam Perrone; Giulia Dondi; Pierandrea De Iaco; Simone Ferrero; Giuseppe Sarpietro; Maria G Matarazzo; Antonio Cianci; Stefano Cianci; Sara Bosio; Simona Ruisi; Lavinia Mosca; Raffaele Tinelli; Rosa De Vincenzo; Gian Franco Zannoni; Gabriella Ferrandina; Marco Petrillo; Giampiero Capobianco; Salvatore Dessiole; Annunziata Carlea; Fulvio Zullo; Barbara Muschiato; Stefano Palomba; Stefano Greggi; Arsenio Spinillo; Fabio Ghezzi; Nicola Colacurci; Roberto Angioli; Pierluigi Benedetti Panici; Ludovico Muzii; Giovanni Scambia; Francesco Raspagliesi; Violante Di Donato Journal: Vaccines (Basel) Date: 2022-04-09
Authors: Fábio Russomano; Maria Aparecida Pereira Tristao; Renata Côrtes; Maria José de Camargo Journal: BMC Womens Health Date: 2015-02-18 Impact factor: 2.809