Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at
 Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination
 against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the
 percentage of cervical lesion recurrence among a group of treated and vaccinated women
 against HPV between the years 2015-2018 will be compared with a control group of treated and
 non-vaccinated women against HPV since 2012-2015.

 It will be an essential requirement that the patient provide a vaccination card from their
 health center where there is proof of their immunization status and date of administration.

 Inclusion criteria:

 -  Women older than 18 years who received excisional therapy due to HSIL /CIN injury
 confirmed histologically.

 -  Women who sign informed consent.

 -  Patients with negative results in the first post-surgery control.

 -  Patients who have received HPV vaccination and provide vaccination card.

 Exclusion criteria:

 -  Women who do not wish or cannot give their informed consent and / or do not comply with
 the requirements of the study.

 -  Patients treated by an indication other than HSIL/CIN.

 -  Patients under immunosuppression conditions.
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at
 Clínico San Carlos Hospital (Madrid) between 2012-2018. The effectiveness of prophylactic
 vaccination against HPV in women treated for HPV-linked disease will be evaluated. For this
 purpose, the percentage of lesional recurrence among a group of treated and vaccinated women
 against HPV between the years 2015-2018 will be compared with a control group of treated and
 non-vaccinated women against HPV since 2012-2015. The data will be obtained through the
 review of clinical records.

 Our protocol is explained above:

 HPV detection method:

 The detection of HPV is performed on a liquid basis by means of the CLARK PAPILOMAVIRUS HUMAN
 test that detects the presence of the HPV virus (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42,
 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71.72, 73, 81, 82, 83, 84, 85 and
 89). The test has a diagnostic sensitivity of 98.2% and a diagnostic specificity of 100% and
 analytical specificity: 100%. The analytical sensitivity of this test is 100% when the number
 of copies is 1,000 or 10,000 depending on the type of HPV. The Laboratory has carried out
 external quality control of the SEAP.

 Pre-surgical evaluation:

 Those patients with an abnormal cytological result and / or positive HPV tests were referred
 to the PTGI consultations of Clínico San Carlos Hospital for evaluation according to the
 Cervical Cancer Prevention Guidelines issued by the Spanish Association of Cervical Pathology
 and Colposcopy (AEPCC) in 2006 and 2014. These patients underwent colposcopy with biopsy if
 necessary +/- determination of HPV. Patients diagnosed with HSIL / CIN 2+ who met the
 inclusion criteria were submitted to cervical conization and subsequently enrolled in the
 study after signing the informed consent, approved by ethics commission.

 We will take into account the date of administration of the first dose of vaccine. The types
 of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent
 (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not
 funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To
 define the time of vaccination around the conization date, the administration of the first
 dose of vaccine will be taken into account.

 Surgical treatment:

 Excisional therapy was performed in the operating room on a scheduled basis under local
 analgesia and sedation. After infiltration with local anesthetic and vasoconstrictor in the 4
 quadrants of the cervix, excisional therapy with diathermic loop is performed under
 colposcopy control, obtaining the piece in a single specimen. The piece is oriented with a
 long thread at 12:00 h, it is introduced in formaldehyde and send to pathological anatomy for
 deferred study. In all cases, immediate endocervical curettage post-treatment was performed.

 Clinical follow-up:

 The first revision is made 30 days after surgery where patient is informed of histological
 results and the date on first control post-treatment based on the diagnosis.

 Following the protocol of the AEPCC, in case of non-involvement of margins and negative
 endocervical curettage, the patient comes after 6 months from the intervention to perform the
 first post-surgery control with co-test. In case of positive endocervical curettage or margin
 involvement, the first post-surgery control will be performed at 4 months with cotest +
 endocervical study and colposcopy. Persistent disease is defined as the presence of
 cytological alteration and / or HPV infection in the first post control performed at 4-6
 months after excisional therapy. These patients are excluded from the study, since only those
 in which both tests are negative will be included.

 Subsequently, a new co-test was performed at 12 months, 24 months and 36 months after the
 first post-surgery control. After 3 years of negative testing, the patient is returned to the
 current cervical cancer-screening program.
Inclusion Criteria:

 -  Women older than 18 years who received excisional therapy due to HSIL /CIN injury
 confirmed histologically.

 -  Women who sign informed consent.

 -  Patients with negative results in the first post-surgery control.

 -  Patients who have received HPV vaccination and provide vaccination card.

 Exclusion Criteria:

 -  Women who do not wish or cannot give their informed consent and / or do not comply
 with the requirements of the study.

 -  Patients treated by an indication other than HSIL/CIN.

 -  Patients under immunosuppression conditions.