Intraoperative post-conization human papillomavirus testing: an earlier predictive factor of recurrences in patients treated for cervical intraepithelial neoplasia

Abstract

Background: Human papillomavirus (HPV) testing is now the better predictive factor of recurrent disease during follow-up in women operated for cervical intraepithelial neoplasia grades 2-3. The time between the surgery and the first HPV test depends on the surgical margins: 6 months (if margins are negative) and 4 months (if margins are positive). So, we have to wait a considerable time to know if the virus is still present after the treatment. Purpose: The aim of the present work is to determine if the effectiveness of human papillomavirus testing performed in the same surgical procedure (immediately after the conization), is the same in comparison to human papillomavirus testing performed after 4-6 months of the operation. In this way, cases with recurrent disease during follow-up would be earlier predicted. Design: Prospective, observational and multicentric study. Population: Women diagnosed with cervical intraepithelial neoplasia grades 2-3 undergoing cervical conization in a public hospital located in the province of Girona, between 2017 and 2020. Methods: An endocervical sample will be obtained intraoperatively with a cytobrush from the cervix remaining after the conization. The material will be kept in Specimen Transport Medium and processed using the commercially available Hybrid Capture System. Patients will be followed-up for 3 years. The intraoperative HPV test will be compared with HPV test at 4 and 6 months. It will also be compared with the conventional cone margins indicator of recurrences