Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence

The procedure was performed under spinal anesthesia, with the patients in lithotomy position. Ten 2-mm perianal skin incisions were made 1-2 cm from the anal margin (i.e., 0.5-1 cm from the intersphinteral sulcus), equidistant one each other, around the entire anal circumference, to allow implantation of 10 prostheses using a specifically designed delivery system (THD Sphinkeeeper Delivery System, THD Sp, Correggio, Italy). The introducer was placed through each skin incision in the intersphincteric space where the prostheses were delivered at a level below the puborectalis muscle. All of the steps were verified by palpation and direct vision using the Eisenhammer anal speculum. Patients were discharged on the same day and recommended to avoid any trauma or sexual practice during the first 48 hours after implantation. A 5-day course of antibiotics was also prescribed.