Intraoperative conduct in women with adnexal masses undergoing or not frozen section biopsy

• Grant number: 23/01905-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): April 01, 2023
• Effective date (End): September 30, 2024
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Sophie Françoise Mauricette Derchain
• Grantee: Leonardo Octavio Lobo Soares
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

Introduction: Once the woman with an adnexal mass undergoes surgery, the histological diagnosis can be given through intraoperative frozen section biopsy or the result of the paraffin analysis is awaited. The purpose of the intraoperative frozen section is to investigate the type and stage of disease and guide the surgeon in the extent of resection, with particular concern for fertility preservation, complete staging, or cytoreduction. Objective: To compare the intraoperative surgical approach in women undergoing laparotomy or laparoscopy due to adnexal mass depending on whether or not a frozen biopsy was performed. Evaluate the clinical characteristics of the women according to the performance of the frozen biopsy and evaluate the accuracy of the frozen biopsy in relation to the definitive diagnosis in paraffin. Subjects and methods: This is a cross sectional study. All women with adnexal masses treated between 2010 and 2021, whose initial diagnostic/therapeutic surgery was performed at CAISM and who signed the Free and Informed Consent Term of protocol 1092/2009 approved by the Unicamp Research Ethics Committee, will be included. Around 150 to 200 women are admitted to the CAISM ovarian clinic each year, referred for adnexal mass. Of these, about 55% undergo surgery and will be eligible for the survey. With this, it is estimated to include 1100 cases. This sample size will be sufficient to meet the objectives above, considering an alpha-type error of 5% and a beta-type error of 20%. Data processing and analysis: A database will be created by the researcher in Excel Software for Windows 11. Data analysis will be performed together with the CAISM statistical service using the SAS 8.2® program or R package for statistical analysis® or Epi-Info version 7®.