title: Ultrasonographic evidence of Gatekeeper™ prosthesis migration in patients treated for faecal incontinence: a case series.
abstract: BACKGROUND
  Faecal incontinence (FI) is both a medical and social problem, with an underestimated incidence. For patients with internal anal sphincter damage, implantation of biomaterial in the anal canal is a recognised treatment option. One such material, Gatekeeper™, has previously shown promising short- and medium-term results without any major complications, including displacement. The main aim of the present study is to assess the degree to which displacement of Gatekeeper prostheses may occur and to determine whether this is associated with patient outcomes.
  
  
  METHODS
  Seven patients (six females) with a mean age of 55.6 years [50.5-57.2] and a mean FI duration of 6 ± 2 years were prospectively enrolled in the study. Each subject was anaesthetised and underwent implantation of six prostheses in the intersphincteric region, guided by endoanal 3D ultrasound (3D-EAU). Follow-up was performed at post-interventional months 1, 3, and 12 (median 12 ± 4 months), during which data were obtained from a defaecation diary, Wexner scale assessment, anorectal manometry (ARM), 3D-EAU, and a health status and quality of life questionnaire (FIQL).
  
  
  RESULTS
  At 3-month follow-up, 3D-EAU revealed displacement of 24/42 prostheses in 5/7 patients. Of these, 15 had migrated to the lower portion and 9 to the upper portion of the anal canal and rectum. Despite this migration, treatment was considered successful in 3/7 patients. In one patient, it was necessary to remove a prosthesis due to spontaneous extrusion.
  
  
  CONCLUSIONS
  We have shown that displacement of the Gatekeeper™ prosthesis occurs, but is not associated with poorer clinical outcomes.
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain. fportilla@us.es.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD o Ciberehd), Instituto de Salud Carlos III, Madrid, Spain. fportilla@us.es.
authors.forename: F
authors.initials: F
authors.lastname: de la Portilla
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: M L
authors.initials: ML
authors.lastname: Reyes-Díaz
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: M V
authors.initials: MV
authors.lastname: Maestre
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: R M
authors.initials: RM
authors.lastname: Jiménez-Rodríguez
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: A M
authors.initials: AM
authors.lastname: García-Cabrera
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Vázquez-Monchul
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Díaz-Pavón
authors.affiliation: Coloproctology Unit. Clinical Management Unit of General and Gastrointestinal Surgery Division, Seville Biomedical Research Institute (IBIS). University Hospital Virgen del Rocío/CSIC/University of Seville, Avda Manuel Siurot s/n, 41013, Seville, Spain.
authors.forename: F C
authors.initials: FC
authors.lastname: Padillo-Ruiz
mesh_terms: D005242:Fecal Incontinence / Q000000981:diagnostic imaging* / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D019736:Prostheses and Implants; D011475:Prosthesis Failure; D011788:Quality of Life; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: Endoanal ultrasound; Faecal incontinence; Migration; Prostheses; Results