Efficacy of Sphinkeeper™ implant in treating faecal incontinence

Litta, Francesco; Parello, Angelo; Simone, Veronica De; Campennì, Paola; Orefice, Raffaele; Marra, Angelo Alessandro; Goglia, Marta; Moroni, Rossana; Ratto, Carlo

doi:10.1002/bjs.11558

Cited by 23 publications

(34 citation statements)

References 15 publications

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“…Our results are more akin to those of Litta et al . [30]. Using follow‐up EAUSS assessment of prosthetics, they found that the implantation was adequate in only 23 of the 42 patients (based on 6/10 prostheses placed in the target area).…”

Section: Discussionmentioning

confidence: 99%

“…The total number of prostheses and their position relative to the sphincter complex in the anal canal were reviewed. The location of the prostheses was categorized as either in an ideal position (the proximal intersphincteric space) or in a sub-optimal position (migrated distally or outside of the intersphincteric plane) [30].…”

Section: Review Of Postoperative Imagingmentioning

confidence: 99%

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Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two‐centre retrospective clinical audit

et al. 2020

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Aim The SphinKeeper TM artificial bowel sphincter implant is a relatively new surgical technique for the treatment of refractory faecal incontinence. This study presents the first experience in two UK tertiary centres. Method This is a retrospective audit of prospectively collected clinical data in relation to technique, safety, feasibility and short-term effectiveness from patients undergoing surgery from January 2016 to April 2019. Baseline data, intra-operative and postoperative complications, symptoms [using St Mark's incontinence score (SMIS)] and radiological outcomes were analysed. Results Twenty-seven patients [18 women, median age 57 years (range 27-87)] underwent SphinKeeper. In 30% of the patients, the firing device jammed and not all prostheses were delivered. There were no intra-operative complications and all patients were discharged the same or the following day. SMIS significantly improved from baseline [median À6 points (range À12 to +3); P < 0.00016] with 14/27 (51.9%) patients achieving a 50% reduction in the SMIS score. On postoperative imaging, a median of seven prostheses (range 0-10) were identified with a median of five (range 0-10) optimally placed. There was no relationship between number of well-sited prostheses on postoperative imaging and categorical success based on 50% reduction in SMIS (v 2 test, P = 0.79). Conclusion SphinKeeper appears to be a safe procedure for faecal incontinence. Overall, about 50% patients achieved a meaningful improvement in symptoms. However, clinical benefit was unrelated to the rate of misplaced/migrated implants. This has implications for confidence in proof of mechanism and also the need for technical refinement.

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Section: Discussionmentioning

confidence: 99%

Section: Review Of Postoperative Imagingmentioning

confidence: 99%

Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two‐centre retrospective clinical audit

et al. 2020

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“…Mimicking anal sphincter muscle, the SphinKeeper™ is considered to improve FI [2]. Indeed, early experience showed a significant reduction of incontinence episodes in 50% of operated patients [3]. Currently, data are scarce, and its definite role in the management of FI still needs to be defined.…”

Section: Dear Editormentioning

confidence: 99%

Re‐Do Sphinkeeper™ procedure for treating recurrent faecal incontinence – a video vignette

et al. 2021

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“…It has also been suggested that an implanted prosthesis increases muscle fibre length, and therefore contributes to an enhanced contractility [ 5 ]. Few clinical studies are available, showing success rates in up to 50% of treated patients [ 6 , 7 , 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

“…To date, literature on the Sphinkeeper is scarce; thus, its role in the management of FI is not yet well defined. Notably, a low number of short-term studies showed promising results with a significant decline in incontinence episodes [ 5 , 6 , 7 , 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Sphinkeeper Procedure for Treating Severe Faecal Incontinence—A Prospective Cohort Study

Dawoud

Bender

Widmann

et al. 2021

JCM

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(1) Background: The Sphinkeeper implantation for faecal incontinence (FI) is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper surgery in patients with refractory FI. (2) Methods: Between 2018 and 2020, eleven consecutive patients (9 female) with FI met the inclusion criteria and were enrolled for surgery. Functional outcome and quality of life were evaluated by standard questionnaires pre- and post-surgery. Migration of protheses was demonstrated by 3D endoanal ultrasound. The median follow-up time was eight months (range 3–18 months). (3) Results: The median age was 75 years (range 46–89 years) with a median BMI of 27.4 (range 21.2–30.1). The median number of implanted prostheses per intervention was nine (range 9–10). We found no intraoperative or early postoperative complications. After two months, two prostheses in one patient had to be removed due to pain at the perianal skin site. The median St. Mark’s incontinence score decreased significantly from 22 to 13 points (p = 0.008). The SF-12 showed a significant improvement (35.9 versus 46.3) after surgery (p = 0.028). A migration of at least one prosthesis was observed in ten patients (91%). Six (60%) prostheses were found at the same level in another ten patients. (4) Conclusion: Sphinkeeper implantation is a promising surgical technique for patients with severe FI. The complication rate is low, and short-term functional improvement can be achieved even in severe forms of FI. Migration of implants commonly occurs.

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Efficacy of Sphinkeeper™ implant in treating faecal incontinence

Cited by 23 publications

References 15 publications

Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two‐centre retrospective clinical audit

Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two‐centre retrospective clinical audit

Re‐Do Sphinkeeper™ procedure for treating recurrent faecal incontinence – a video vignette

Sphinkeeper Procedure for Treating Severe Faecal Incontinence—A Prospective Cohort Study

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