Fecal incontinence following anterior resection and neoadjuvant therapy should be carefully evaluated. If a suspected neurogenic pathogenesis is confirmed, sacral neuromodulation may be proposed. If the test results are positive, permanent implant is advisable. Failure of this approach does not exclude the use of other, more aggressive treatment.

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IntroductionA new artificial anal sphincter, SphinKeeperTM, 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.MethodsSphinKeeperTM 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.ResultsTen patients (5 females; median age 58 years, range 20–75) were enrolled and treated with SphinKeeperTM 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.ConclusionSphinKeeperTM 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.

BackgroundA 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.MethodsPatients 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.ResultsFifty‐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.ConclusionAnal implantation of the Gatekeeper™ in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1‐year follow‐up.