Abstract
BackgroundAnal fissure (AF) is a common, painful disease that strongly affects patients’ quality of life, however, no scoring system to assess the severity of AF is available in the literature. The aim of this study was to set up and validate a reliable scoring system to quantify the severity of AF, to be used in prospective trials comparing the efficacy and the outcomes of surgical or medical treatments.MethodsThe study was conducted on patients with acute or chronic AF and a control group in a tertiary centre for coloproctology in June 2020–September 2020. Two researchers independently carried out a structured interviewer-led questionnaire at two different time points (T1/T2). The questionnaire consisted of five items selected according to the most commonly reported symptoms for AF: the item pain, was scored from 0 to 10 using a visual analogue scale, and quality of life, duration of pain, use of painkillers, and bleeding were scored from 1 to 5 using Likert-scale questions. The scoRing systEm for AnaL fIsSurE (REALISE) score was the sum of the points. Patients with AF and a control group of patients with haemorrhoids, anal fistula, or obstructed defecation syndrome entered the study. Main outcome measures were reliability, inter-/intraobserver agreement, and repeatability.ResultsOne hundred and fifty well-matched patients (75 with AF and 75 controls) were enrolled. A significant difference was found between the mean REALISE score for patients with AF and controls (p < 0.001). The two REALISE scores were highly correlated (r = 0.99). The coefficient of repeatability was 1.45 in T1 and 1.18 in T2.ConclusionsThe REALISE score may have an important role in the assessment and management of AF, in grading the severity of AF and comparing results of different treatments.
Highlights
Anal fissure (AF) is a very common anorectal condition which affect both sexes [1] and is often associated with elevated internal anal sphincter pressure [2, 3]
The control group included patients complaining similar anal symptoms due to different diseases instead of healthy subjects to evaluate the discriminatory power of the scoRing systEm for AnaL fIsSurE (REALISE) score
Out of 75 patients belonging to the control group, 51 (68%) had haemorrhoids, 17 (22.6%) had an anal fistula and 7 (9.4%) had obstructed defecation
Summary
Anal fissure (AF) is a very common anorectal condition which affect both sexes [1] and is often associated with elevated internal anal sphincter pressure [2, 3]. Anal fissure (AF) is a common, painful disease that strongly affects patients’ quality of life, no scoring system to assess the severity of AF is available in the literature. The aim of this study was to set up and validate a reliable scoring system to quantify the severity of AF, to be used in prospective trials comparing the efficacy and the outcomes of surgical or medical treatments. The scoRing systEm for AnaL fIsSurE (REALISE) score was the sum of the points. A significant difference was found between the mean REALISE score for patients with AF and controls (p < 0.001). Conclusions The REALISE score may have an important role in the assessment and management of AF, in grading the severity of AF and comparing results of different treatments
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