Re-conization versus follow-up to women with affected exocervical margins after conization for H-SIL or L-SIL: a clinical trial

Abstract

BACKGROUND Cervical cancer is the third neoplasia among worldwide. It is known, that cervical carcinogenesis is based on the persistence of HPV infection. Fortunately, screening protocols have been recently applied. Those protocols showed great results reducing invasive cancers and offering less invasive techniques due to early detection. The screening with cytology should be performed to women between 25 and 30 years, every 3 years. It’s done by HPV tests every 5 years in women between 35 and 60 years old. Treating precancerous injuries is effective, although, the number of women treated is increasing. The main techniques applied to find out precancerous lesions such us L-SIL and H-SIL are cytology, colposcopy and HPV detection. The main technique to treat them is the conization (LEEP procedure). Once a precancerous lesion is confirmed a resection procedure must be done to avoid the progression of the lesion. After that, if the histological margins aren’t affected the patient should be followed-up among 20 years. But if the results show affected margins, either the patient can be followed-up or the conization can be repeated. OBJECTIVE

The aim of this study is to compare the local recurrence between follow-up procedures and re- conization, in women with positive exocervical margins after conization (either for HSIL or LSIL).

STUDY DESING AND POPULATION A randomized controlled clinical trial will be done. It will be a multicentric study performed on the Province of Girona between the 2019 and 2023. The sample size will be of 144 patients who meet inclusion criteria. METHODS The main variables will be: local recurrence confirmed by histology and following-up or re-conization. The following covariables will be considered: age, gravidity, tobacco, alcohol, IMC, HPV, HPV vaccination, STD and number of sexual partners. The patients with LSIL will be classified in two groups randomly: the follow-up group and the re-conization group. The same distribution will be applied for the HSIL patients. Those patients will be followed-up for two years and the local recurrence will be analysed and compared in the two different groups