title: Implantation of SphinKeeper(TM): a new artificial anal sphincter.
abstract: BACKGROUND
  A new artificial anal sphincter, SphinKeeper(TM), was devised with the aim to treat fecal incontinence (FI) by implanting specifically designed self-expandable prostheses into the intersphincteric space. Preliminary data concerning the procedure feasibility and prosthesis localization at 3 months are presented.
  
  
  METHODS
  SphinKeeper(TM) prostheses in the native state are dehydrated, thin, solid cylinder (length 29 mm, diameter 3 mm), changing their state (shorter--length 23 mm, thicker--diameter 7 mm--and softer, with shape memory) within 48 h of contact with fluids. In this study, 10 prostheses were implanted in each patient with FI under local anesthesia and under endoanal ultrasound (EAUS) guidance, into the upper-middle intersphincteric space of the anal canal by a specifically designed delivery system. EAUS was used postoperatively to assess prostheses dislocation.
  
  
  RESULTS
  Ten patients (5 females; median age 58 years, range 20-75) were enrolled and treated with SphinKeeper(TM) implantation. Median duration of procedure (performed by endoanal ultrasound guidance) was 40 min (range 30-45). Neither intraoperative nor postoperative complications were reported after a 3-month follow-up. In one patient, a partial dislocation of a single prosthesis was documented by EAUS, causing anal discomfort which resolved after 1 week.
  
  
  CONCLUSIONS
  SphinKeeper(TM) can be safely implanted in patients with FI of different etiology. Implantation was well tolerated with no dislodgment of implants at 3-month follow-up.
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy. carloratto@tiscali.it.
authors.forename: C
authors.initials: C
authors.lastname: Ratto
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Donisi
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Litta
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Campennì
authors.affiliation: Proctology Unit, Department of Surgical Sciences, Catholic University, Largo A. Gemelli, 8, 00168, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Parello
mesh_terms: D000328:Adult; D000368:Aged; D001003:Anal Canal / Q000000981:diagnostic imaging / Q000601:surgery; D001187:Artificial Organs; D019160:Endosonography / Q000379:methods; D005242:Fecal Incontinence / Q000000981:diagnostic imaging / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications / Q000000981:diagnostic imaging; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D000067368:Transanal Endoscopic Surgery / Q000295:instrumentation / Q000379:methods*; D055815:Young Adult
keywords: Artificial anal sphincter; Bulking agents; Dynamic graciloplasty; Fecal incontinence; Gatekeeper; Sacral nerve stimulation; Sphincter lesion; Sphincteroplasty