French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease.

PURPOSE: The aim of this study was to evaluate the efficacy and safety of radiofrequency ablation (RFA) in the management of haemorrhoidal disease with 1 year's follow-up. METHOD: This prospective multicentre study assessed RFA (Rafaelo©) in outpatients with grade II-III haemorrhoids. RFA was performed in the operating room under locoregional or general anaesthesia. Primary endpoint was the evolution of a quality-of-life score adapted to the haemorrhoid pathology (HEMO-FISS-QoL) 3 months after surgery. Secondary endpoints were evolution of symptoms (prolapsus, bleeding, pain, itching, anal discomfort), complications, postoperative pain and medical leave. RESULTS: A total of 129 patients (69% men, median age 49 years) were operated on in 16 French centres. Median HEMO-FISS-QoL score dropped significantly from 17.4/100 to 0/100 (p < 0.0001) at 3 months. At 3 months, the rate of patients reporting bleeding (21% vs. 84%, p < 0.001), prolapse (34% vs. 91.3%, p < 0.001) and anal discomfort (0/10 vs. 5/10, p < 0.0001) decreased significantly. Median medical leave was 4 days [1-14]. Postoperative pain was 4/10, 1/10, 0/10 and 0/10 at weeks 1, 2, 3 and 4. Seven patients (5.4%) were reoperated on by haemorrhoidectomy for relapse, and three for complications. Reported complications were haemorrhage (3), dysuria (3), abscess (2), anal fissure (1), external haemorrhoidal thrombosis (10), pain requiring morphine (11). Degree of satisfaction was high (+ 5 at 3 months on a - 5/+ 5 scale). CONCLUSION: RFA is associated with an improvement in quality of life and symptoms with a good safety profile. As expected for minimally invasive surgery, postoperative pain is minor with short medical leave. CLINICAL TRIAL REGISTRATION AND DATE: Clinical trial NCT04229784 (18/01/2020).

Psychometric properties of a questionnaire (HEMO-FISS-QoL) to evaluate the burden associated with haemorrhoidal disease and anal fissures.

AIM: Current questionnaires designed to evaluate the burden of haemorrhoidal disease ignore symptoms such as bleeding, pain and itching. A specific questionnaire is needed to evaluate the global impact of anal disorders on patients' daily lives. METHOD: We developed a questionnaire (HEMO-FISS-QoL) to assess the symptom burden of anal disorders and administered it to 256 patients (mean age 46.2 years; men 60.4%) with haemorrhoidal disease (67.2%), anal fissure (29.3%) or both (3.5%). Psychometric properties were evaluated by testing the acceptability, construct validity and reliability of the questionnaire. Principal components and multi-trait analyses were used to identify dimensions and to assess construct validity. Backward Cronbach alpha curves and a graded response model were used to reduce the number of items and modalities. External validity was evaluated against SF-12 and the Psychological Global Well-Being Index (PGWBI) using Spearman's correlation coefficient. RESULTS: Principal component analysis defined four dimensions: physical disorders, psychology, defaecation and sexuality. The number of questions was reduced from 38 to 23. The HEMO-FISS-QoL scores correlated well with those of the SF-12 and PGWBI (P < 0.001). Cronbach's coefficients (all > 0.7) reflected good internal reliability of the different dimensions. The total score increased with the severity of the anal disorders and with their consequences (days off work and personal spending related to the disease). CONCLUSION: The HEMO-FISS-QoL questionnaire reliably evaluates the global impact of haemorrhoids and anal fissures on patients' daily lives. This simple tool may prove useful for treatment evaluation in clinical trials and daily practice.