OBJECTIVES: The haemorrhoidal disease is a frequent and chronic illness. The anal fissure is the second reason of proctologic medical visits. At the moment, there is only a clinical score measuring the grade of the haemorrhoids, but the impact of the disease on the patients’ quality of life is not evaluated. The objective of this study is to validate a specific questionnaire to evaluate the burden of the haemorrhoidal disease and anal fissure (HEMO-FISS) on the patients’ daily life. METHODS: The questionnaire HEMO-FISS, including 38 questions, has been submitted to patients suffering from a haemorrhoidal disease or an anal fissure and, consulting a participating proctologist in France during the study period (2012-2014). The psychometric properties were evaluated by testing the acceptability, construct validity and reliability. A principal component analysis (PCA) using Varimax rotation, a Spearman correlation coefficient with SF-12 and PGWBI and a multi-trait analysis (MTA) were conducted to assess the construct validity of the questionnaire. The reliability was evaluated using Cronbach’s alpha coefficient (CAC). Backward Cronbach alpha curves (BCAC) were drawn. RESULTS: :A total of 256 patients were included in the study. Following the factor analysis, four dimensions were defined: physical disorders, psychology, troubles defecating and sexuality. The number of questions was reduced from 38 to 28. Item reduction was based on MTA and BCAC. A strong correlation was observed between SF-12 and the dimensions regarding physical disorders (with PCS) and psychology (with MCS). The Cronbach’s coefficient (all > 0.7) reflected a good internal consistency of the different dimensions of the questionnaire. CONCLUSIONS: The questionnaire HEMO-FISS displays good properties to evaluate the burden of haemorrhoids and anal fissures. Consecutive to this preliminary validation, a graded response model (GRM) will be developed to precise the unidimensionality of each dimensions.