Portuguese Inguinal Hernia Cohort (PINE) study

Abstract Purpose Recent comprehensive guidelines have been published on the management of inguinal hernia. Contrary to other European countries, no Portuguese hernia registry exists. This represents an opportunity to assess outcomes of hernia surgery in the Portuguese population. The primary aim is to define the prevalence of chronic pain after elective inguinal hernia repair. The secondary aims are to identify risk factors for chronic pain after elective inguinal hernia repair, to characterise the management of elective inguinal hernia in public Portuguese hospitals. Methods Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery. Conclusion This protocol describes the methodology of a prospective cohort study on the elective management of inguinal hernia. It discusses key challenges and describes how the results will impact future investigation. The study will be conducted across a nationwide collaborative research network, with prospective quality assurance and data validation strategies. It will provide the basis for a more accurate prediction of chronic postoperative inguinal pain and the research on adequate patient selection strategies for surgery and therapeutic strategies for postoperative pain.