title: Prospective evaluation of a new device for the treatment of anal fistulas.
abstract: OBJECTIVE
  To evaluate the safety of the implantation of a new device for the treatment of anal fistulas. The short-term clinical efficacy was also assessed.
  
  
  METHODS
  This study took place at a tertiary care university hospital. Patients with a complex anal fistula of cryptoglandular origin were enrolled in the study and were treated with insertion of the new device. All patients were evaluated by clinical and physical examination, including an endoanal ultrasound at the baseline, and then at the 2 wk and 1, 2, 3 and 6-mo follow-up visits.
  
  
  RESULTS
  Morbidity, continence status, and success rate were the main outcome measures. Ten patients underwent the placement of the new device. The fistulas were transphincteric in eight patients and extrasphincteric in the remaining two. The median duration of the surgical procedure was 34.5 (range, 27-42) min. Neither intra- nor postoperative complications occurred, and all patients were discharged the day after the procedure. At the 6-mo follow-up evaluation, the final success rate was 70%. Three failures were registered: a device expulsion (on the 10(th) postoperative day), the persistence of inflammatory tissue around the fistula tract (at the 2-mo follow up), and the persistence of serum discharge (at the 6-mo follow up). No patient experienced any change incontinence, as assessed by the Cleveland Clinic Fecal Incontinence score.
  
  
  CONCLUSIONS
  The technical procedure is simple and has low risk of perioperative morbidity. The pre- and post-operative continence status did not change in any of the patients. The initial results at the 6-mo follow up seem to be promising. However, a longer follow-up period and a larger sample size are needed to confirm these preliminary results.
authors: Carlo Ratto, Francesco Litta, Lorenza Donisi, Angelo Parello, Proctology Unit, Department of Surgical Sciences, Catholic University, 00168 Rome, Italy.
authors: Carlo
authors: C
authors: Ratto
authors: Carlo Ratto, Francesco Litta, Lorenza Donisi, Angelo Parello, Proctology Unit, Department of Surgical Sciences, Catholic University, 00168 Rome, Italy.
authors: Francesco
authors: F
authors: Litta
authors: Carlo Ratto, Francesco Litta, Lorenza Donisi, Angelo Parello, Proctology Unit, Department of Surgical Sciences, Catholic University, 00168 Rome, Italy.
authors: Lorenza
authors: L
authors: Donisi
authors: Carlo Ratto, Francesco Litta, Lorenza Donisi, Angelo Parello, Proctology Unit, Department of Surgical Sciences, Catholic University, 00168 Rome, Italy.
authors: Angelo
authors: A
authors: Parello
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D013505:Digestive System Surgical Procedures / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012003:Rectal Fistula / Q000601:surgery*; D013525:Surgical Instruments
keywords: Anal fistula; Device; Endoanal ultrasound; Faecal incontinence; Fistula plug; Recurrence