Implantation of SphinKeeper(TM): a new artificial anal sphincter

C Ratto, L Donisi, F Litta, P Campennì, A Parello, C Ratto, L Donisi, F Litta, P Campennì, A Parello

Abstract

Introduction: 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.

Conclusion: 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.

Keywords: Artificial anal sphincter; Bulking agents; Dynamic graciloplasty; Fecal incontinence; Gatekeeper; Sacral nerve stimulation; Sphincter lesion; Sphincteroplasty.

Figures

Fig. 1
Fig. 1
SphinkeeperTM prosthesis as appears in the native, dehydrated condition (a) and following hydration (b)
Fig. 2
Fig. 2
SphinkeeperTM delivery system, showing, in detail, the dispenser containing the prosthesis
Fig. 3
Fig. 3
Site of SphinkeeperTM implantation within the interspincteric space
Fig. 4
Fig. 4
3D-endoanal ultrasound showing the implanted SphinkeeperTM prostheses as imaged at the end of operation (a, b) and 1 week after (c, d)
Fig. 5
Fig. 5
3D-endoanal ultrasound showing the implanted SphinkeeperTM prostheses in a patient with sphincter lesion, imaged at the end of operation (a, b) and within 1 week after (c, d)

References

    1. Paquette IM, Varma MG, Kaiser AM, Steele SR, Rafferty JF. The American Society of Colon and Rectal Surgeons’ clinical practice guideline for the treatment of fecal incontinence. Dis Colon Rectum. 2015;58:623–636. doi: 10.1097/DCR.0000000000000397.
    1. Hayden DM, Weiss EG. Fecal incontinence: etiology, evaluation, and treatment. Clin Colon Rectal Surg. 2011;24:64–70. doi: 10.1055/s-0031-1272825.
    1. Hull T. Fecal incontinence. Clin Colon Rectal Surg. 2007;20:118–124. doi: 10.1055/s-2007-977490.
    1. Brown HW, Wexner SD, Segall MM, Brezoczky KL, Lukacz ES. Accidental bowel leakage in the mature women’s health study: prevalence and predictors. Int J Clin Pract. 2012;66:1101–1108. doi: 10.1111/ijcp.12018.
    1. Brown HW, Wexner SD, Lukacz ES. Factors associated with care seeking among women with accidental bowel leak-age. Female Pelvic Med Reconstr Surg. 2013;19:66–71. doi: 10.1097/SPV.0b013e31828016d3.
    1. Bharucha AE, Fletcher JG, Melton LJ, Zinsmeister AR. Obstetric trauma, pelvic floor injury and fecal incontinence: a population-based case-control study. Am J Gastroenterol. 2012;107:902–911. doi: 10.1038/ajg.2012.45.
    1. Nelson RL. Epidemiology of fecal incontinence. Gastroenterology. 2004;126:S3–S7. doi: 10.1053/j.gastro.2003.10.010.
    1. Van Koughnett JA, Wexner SD. Current management of fecal incontinence: choosing amongst treatment options to optimize outcomes. World J Gastroenterol. 2013;19:9216–9230. doi: 10.3748/wjg.v19.i48.9216.
    1. Ratto C, Parello A, Donisi L, et al. Novel bulking agent for faecal incontinence. Br J Surg. 2011;98:1644–1652. doi: 10.1002/bjs.7699.
    1. Ratto C, Buntzen S, Aigner F, et al. Multicentre observational study of Gatekeeper for faecal incontinence. Br J Surg. 2015
    1. Jorge JMN, Wexner SD. Etiology and management of faecal incontinence. Dis Colon Rectum. 1993;36:77–97. doi: 10.1007/BF02050307.
    1. Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999;44:77–80. doi: 10.1136/gut.44.1.77.
    1. American Medical Systems Fecal incontinence scoring system (1996) American Medical Systems, Minnetonka
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483. doi: 10.1097/00005650-199206000-00002.
    1. Rockwood TH, Church JM, Fleshman JW, et al. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000;43:9–16. doi: 10.1007/BF02237236.
    1. Gordon AM, Huxley AF, Julian FJ. The variation in isometric tension with sarcomere length in vertebrate muscle fibres. J Physiol. 1966;184:170–192. doi: 10.1113/jphysiol.1966.sp007909.
    1. Rajasekaran MR, Jiang Y, Bhargava V, et al. Length-tension relationship of the external anal sphincter muscle: implications for the anal canal function. Am J Physiol Gastrointest Liver Physiol. 2008;295:G367–G373. doi: 10.1152/ajpgi.00033.2008.
    1. Rajasekaran MR, Jiang Y, Bhargava V, Ramamoorthy S, Lieber RL, Mittal RK. Sustained improvement in the anal sphincter function following surgical plication of rabbit external anal sphincter muscle. Dis Colon Rectum. 2011;54:1373–1380. doi: 10.1097/DCR.0b013e31822d0333.
    1. Mittal RK, Sheean G, Padda BS, Lieber R, Rajasekaran MR. The external anal sphincter operates at short sarcomere length in humans. Neurogastroenterol Motil. 2011;23:643. doi: 10.1111/j.1365-2982.2011.01700.x.
    1. Rajasekaran MR, Jiang Y, Bhargava V, Lieber RL, Mittal RK. Novel applications of external anal sphincter muscle sarcomere length to enhance the anal canal function. Neurogastroenterol Motil. 2011;23:70–75. doi: 10.1111/j.1365-2982.2010.01608.x.
    1. Kim YS, Weinstein M, Raizada V, et al. Anatomical disruption and length-tension dysfunction of anal sphincter complex muscles in women with fecal incontinence. Dis Colon Rectum. 2013;56:1282–1289. doi: 10.1097/DCR.0b013e3182a18e87.

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