title: Multicentre observational study of the Gatekeeper for faecal incontinence.
abstract: BACKGROUND
  A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation.
  
  
  METHODS
  Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up.
  
  
  RESULTS
  Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required.
  
  
  CONCLUSIONS
  Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up.
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Ratto
authors.affiliation: Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: S
authors.initials: S
authors.lastname: Buntzen
authors.affiliation: Department of Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria.|Department of General, Visceral and Transplant Surgery, Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Aigner
authors.affiliation: Department of Emergency and Organ Transplantation, General Surgery Unit, University of Bari, Bari, Italy.
authors.forename: D F
authors.initials: DF
authors.lastname: Altomare
authors.affiliation: Department of General Surgery, Nuovo Ospedale Civile Sant'Agostino Estense, Modena, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Heydari
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Donisi
authors.affiliation: Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Lundby
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Parello
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal / Q000503:physiopathology / Q000601:surgery*; D003672:Defecation / Q000502:physiology*; D005240:Feasibility Studies; D005242:Fecal Incontinence / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome