title: Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas.
abstract: BACKGROUND
  Although interest in sphincter-sparing treatments for anal fistulas is increasing, few large prospective studies of these approaches have been conducted.
  
  
  OBJECTIVE
  The study assessed outcomes after implantation of a synthetic bioabsorbable anal fistula plug.
  
  
  METHODS
  A prospective, multicenter investigation was performed.
  
  
  METHODS
  The study was conducted at 11 colon and rectal centers.
  
  
  METHODS
  Ninety-three patients (71 men; mean age, 47 years) with complex cryptoglandular transsphincteric anal fistulas were enrolled. Exclusion criteria included Crohn's disease, an active infection, a multitract fistula, and an immunocompromised status.
  
  
  METHODS
  Draining setons were used at the surgeon's discretion. Patients had follow-up evaluations at 1, 3, 6, and 12 months postoperatively.
  
  
  METHODS
  The primary end point was healing of the fistula, defined as drainage cessation plus closure of the external opening, at 6 and 12 months. Secondary end points were fecal continence, duration of drainage from the fistula, pain, and adverse events during follow-up.
  
  
  RESULTS
  Thirteen patients were lost to follow-up and 21 were withdrawn, primarily to undergo an alternative treatment. The fistula healing rates at 6 and 12 months were 41% (95% CI, 30%-52%; total n = 74) and 49% (95% CI, 38%-61%; total n = 73). Half the patients in whom a previous treatment failed had healing. By 6 months, the mean Wexner score had improved significantly (p = 0.0003). By 12 months, 93% of patients had no or minimal pain. Adverse events included 11 infections/abscesses, 2 new fistulas, and 8 total and 5 partial plug extrusions. The fistula healed in 3 patients with a partial extrusion.
  
  
  CONCLUSIONS
  The study was nonrandomized and had relatively high rates of loss to follow-up.
  
  
  CONCLUSIONS
  Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure.
authors: 1 Department of Surgery, University of California, Irvine, Irvine, California 2 Department of Surgery, Weill-Cornell-Houston Methodist, Houston, Texas 3 Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana 4 Department of Surgery, Mount Sinai School of Medicine, New York, New York 5 Department of Surgery, Rush University Medical Center, Chicago, Illinois 6 Department of Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 7 Department of Surgery, Weill Medical College, Cornell University, New York, New York 8 Department of Surgery, University of Illinois, Chicago, Illinois.
authors: Michael J
authors: MJ
authors: Stamos
authors: Michael
authors: M
authors: Snyder
authors: Bruce W
authors: BW
authors: Robb
authors: Alex
authors: A
authors: Ky
authors: Marc
authors: M
authors: Singer
authors: David B
authors: DB
authors: Stewart
authors: Toyooki
authors: T
authors: Sonoda
authors: Herand
authors: H
authors: Abcarian
mesh_terms: D058107:Abdominal Wound Closure Techniques; D020341:Absorbable Implants; D013505:Digestive System Surgical Procedures / Q000379:methods*; D004146:Dioxanes / Q000627:therapeutic use; D004322:Drainage / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011100:Polyglycolic Acid / Q000627:therapeutic use; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology; D012003:Rectal Fistula / Q000503:physiopathology / Q000601:surgery*; D013525:Surgical Instruments; D016896:Treatment Outcome; D014481:United States; D014945:Wound Healing
chemical_list: D004146:Dioxanes; D011100:Polyglycolic Acid; C443643:trimethylene carbonate