[Evaluation of the efficacy of a new graduated anal dilator in the treatment of acute anal fissures].

Dilatation of the anal sphincter with anal dilators for the treatment of acute anal fissure is efficacious, economic and safe but not always correctly executed with a negative repercussions on the technical results. Our study was aimed at comparing the efficacy of new graduated dilator with a progressively graduated diameter, using a standard treatment schedule, or a free schedule in comparison with the use of multiple classic dilators currently available for the resolution of anal fissures. A series of 60 patients, 35 female and 25 male, with a clinical diagnosis of acute anal fissure in the absence of a hypotonic anal sphincter, abscess or perianal fistula, hemorrhoidal thrombosis, chronic inflammatory bowel diseases or lower gastrointestinal neoplasms were preliminarily evaluated with the solid sphere test and randomly divided into three groups: the first was treated with the new graduated dilator with a standard treatment schedule (20 patients); the second was treated with multiple anal dilators (20, 23, 27 mm) (20 patients) using a standard treatment schedule, and the third group (20 patients) was treated with the new graduated dilator according to a free treatment schedule. After four weeks of treatment, 91% of all patients showed resolution of the anal fissure. Patients treated with new graduated dilator and those treated with multiple dilators according to the standard schedule showed similar 90% rates of fissure healing in comparison to the 92% treated with the graduated dilator according to the free schedule. The tolerability and manageability of the new single graduated dilator was judged positively by all patients in the treated groups. The use of the graduated anal dilator according to a free treatment schedule seems to induce lasting resolution of acute anal fissures with similar results to those achieved using traditional multiple dilators, while proving better tolerated by the patients.

RCT Entities:   Population Interventions Outcomes