Fecal Incontinence. Sphincter Augmentation. Alaiyan Bilal MD Hadassah mt scopus

Transcription

1 Fecal Incontinence Sphincter Augmentation Alaiyan Bilal MD Hadassah mt scopus

2 AUGMENTATION METHODS Injectables( Bulking agents) Radiofrequency

3 INJECTABLES Biomaterials Polytef, Autologous fat, GAX (glutaraldehyde cross-linked) collagen, PTQ implantstm, Durasphere, Coaptite, Zuidex is dextranomer hyaluronic acid copolymer

4 The ideal agent biocompatible, non-migratory, non-allergenic, nonimmunogenic, non-carcinogenic, easy to inject and produce durable results.

5 INJECTABLES The first report of the use of injectable bulking agents was in 1993 by Shafik - Polytetrafluroethylene (Teflon or Polytef) 11 patients with improvement in all Shafik 14 autologous fat, good shortterm results In 1998 Kumar et al.8 used glutaraldehyde cross-linked collagen 17 pts 11 short term improvement.

6 INJECTABLES Bioplastique, the equivalent of the silicone-based urological product Macroplastique 10 pts 6 months effect. carbon-coated zirconium oxide beads (Durasphere 18 pts partial short term results self-detaching cross-linked silicone microballoons with a biocompatible filler material

7 Mechanism of action augments the natural anal cushions encourages a better seal of the anal canal lumen at rest increases the length of the anal high pressure zone improvement in anal canal symmetry

8 ACYST or DURASPHERE FI Microscopic picture of pyrolitic carbon beads Each carbon bead is µm Suspension of carbon bead in a gel consisting of water and beta-d glucan.

9 Methods of injection Submucosal intersphincteric trans-sphincteric

10 Systematic Review: Route of Injection Increase complications with intersphincteric vs transphincteric and pereanal injection n=969

11 Lack of well-conducted, randomised, controlled trials from which the efficacy of anal bulking agents can be determined.

12 Dextranomer in stabilised hyaluronic acid Randomised, sham-controlled trial Patients from 8 US and 5 European centers Patients randomly assigned to receive (2:1) either anal injection of NASHA Dx (active treatment) or sham treatment After 1 month, all patients with a CCFIS of 10 or more (and no persistent adverse effects) were offered a repeat procedure Graf at al. Lancet 2011

13 Dextranomer in stabilised hyaluronic acid Randomised, sham-controlled trial 206/278 were randomly assigned to receive either active or sham treatment A 50% or greater reduction in the number of incontinence episodes: 71 (52%) patients in the active treatment group 22 (31%) patients in the sham treatment group Odds ratio 2.36, 95% CI , p=0.009). Graf at al. Lancet 2011

14 Dextranomer in stabilised hyaluronic acid Randomised, sham-controlled trial Improved QOL Graf at al. Lancet 2011

15 long-term efficacy and safety of NASHA/Dx, assessed 24 months after treatment. Long-term efficacy of dextranomer in stabilized hyaluronic acid (NASHA/Dx) for treatment of faecal incontinence F. La Torre* and F. de la Portilla *Department of Colorectal and Pelvic Surgery, 1st College of Medicine SAPIENZA, Rome University, Rome, Italy and Coloproctology Unit, Department of General Surgery, Hospital Universitario Virgen del Rocıo, Seville, Spain Received 11 July 2012; accepted 15 December 2012; Accepted Article online 1 February 2013 ª 2013 The Authors Colorectal Disease ª 2013 The Association of Coloproctology of Great Britain and Ireland. 15,

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18 Results 62.7% - responders 50% reduction in FI episodes. The median number of FI episodes declined by 68.8% (P < 0.001). incontinence free days increased from 14.6 to 21.7 at 24 months (P < 0.001). quality of life scores also showed significant improvements.

19 Conclusion NASHA/Dx is safe, effective and durable over a 24-month period

20 Long-term evaluation of bulking agents for the treatment of fecal incontinence: clinical outcomes and ultrasound evidence F. Guerra M. La Torre G. Giuliani D. Coletta S. Amore Bonapasta F. Velluti F. La Torre Tech Coloproctol (2015) 19:23 27

21 Methods median follow-up of 7 years, 19 patients with idiopathic fecal incontinence who had received bulking agent implants were evaluated. BA - Durasphere, PTQ and Solesta subcut. were used. Clinical, manometric and ultrasound assessments were carried out.

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23 methods Median follow-up of 7 years 19 patients with idiopathic fecal incontinence who had received bulking agent implants were evaluated. Clinical, manometric and ultrasound assessments were carried out.

24 Conclusions In the long term, perianally injected bulking agents seem to lose effectiveness.. The ultrasound assessment suggests that the process of resorption is almost complete, and the implants are no longer effective in treating incontinence.

25 Author Results of Injectables N Shafik et al. 14 Material used Autologous Fat Follow -up (month s) Wexner Incontinence score Before After 24 85% improved Shafik et al. 11 PTFE 24 63% improved Malouf et al. 10 Bioplastique 6 30% improved Tjandra et al. 82 Silicone 12 50% improved Tjandra et al. 20 PTQ Sorensen et al. 33 Silicone Weiss et al. 10 ACYST

26 Results of Injectables Davis et al. 18 Dursphere Chan et al. 7 PTQ Stojkovic et al. 73 Contigen De la Portilla et al. 20 PTQ Maeda et al. 10 Bulkamid Permacol Schwander et al. 21 Hyarulonic

27 Systematic Review of Perianal implants Agent No. of studi es Morbid ity (%) n=103 0 Short term success n=458 Long term success n=564 % n % n PTQ Durasphere NASHA TM Permacol Bulkamid TM Coaptite Hussain et al BJS 2011 Fat

28 Conclusions: bulking agents Simple Ambulatory Mild - Moderate to severe incontinence Good short term outcome Minimal complications

29 Radiofrequency (SECCA TM ) Temperature-controlled radiofrequency delivery

30 Radiofrequency (SECCA TM )

31 Radiofrequency (SECCA TM )

32 Results of Radiofrequency Author (year) n F/U (months) Wexner Score Before After QOL Takahashi Efron Takahashi Felt-Bersma * 15* Takahashi Lefebure ** Kim Walega Improved Ruiz Herman Abbas Only 22% improved -- * Vaizey score ** only depression improved

33 Results: Complications Adverse Event n % Mucosal Ulcerations 2 4 % Bleeding Requiring Intervention 12 % Minor Bleeding 5 10 % Antibiotic Induced Diarrhea 7 14 % Fever 2 4 % Vomiting 1 2 % Constipation 1 2 % Groin swelling 1 2 % Hot flashes 1 2 % Efron et al, DCR 2003

34 Secca - Conclusions Ambulatory Simple Relatively safe Variable results