The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

Résumé fourni par la source

Objective: evaluation of a new medical device product based on Rigenase ® : Fitostimoline ® Proctogel which could reduce the pain and favor tissue re-epithelialization by forming a protective barrier towards the anal area.Methods: evaluation of 96 patients equally divided in 3 treatment groups: Group 1: Fitostimoline ® proctogel 2 applications per day; Group 2: Fitostimoline ® proctogel 2 applications per day, in addition to any other topical therapy chosen between the following: Levorag ® , Antrolin ® or Rectogesic ® ; Group 3: a product for topical use, at surgeon choice, between the following: Levorag ® , Antrolin ® or Rectogesic ® .At least one re-evaluation was performed within 1 month, at least a second re-evaluation within 2 months, final evaluation at 4 months.At each checkup, the surgeon filled out the data recording sheet (DRS)-A and the DRS-B, containing personal and clinical data (anamnestic and objectives) and DRS-C, D and E (if the consultation was not clinical, only the part relating to symptoms was filled out).A pharmacoeconomic analysis was also performed.Results: During the second and third visit, a significant improvement of symptoms was observed in the groups 1 and 2 in respect to group 3.Both pain and bleeding were improved during the treatment course.Patients were highly satisfied by the treatment with Fitostimoline ® Proctogel in respect to the other treatments both in terms of efficacy and in cost.Conclusions: Fitostimoline ® proctogel could be a new efficacious and economic tool which can be used for the treatment of fissures.

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