14. Ptq Injections For Faecal Incontinence


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14. Ptq Injections For Faecal Incontinence

  1. 1. PTQ Injections for Faecal Incontinence Michelle Tan Su Wei
  2. 2. Faecal Incontinence <ul><li>Definition </li></ul><ul><li>Continuous or recurrent uncontrolled passage of faecal material (>10mL) for at least one month in an individual older than 3 years of age </li></ul>
  3. 3. Faecal Incontinence <ul><li>Minor incontinence </li></ul><ul><li>Inadvertent escape of flatus or partial soiling </li></ul><ul><li>of undergarments </li></ul><ul><li>Major incontinence </li></ul><ul><li>Involuntary excretion of faeces </li></ul>
  4. 4. Causes of Faecal Incontinence <ul><li>Overflow </li></ul><ul><li>Reduced storage capacity </li></ul><ul><li>Weakness of internal anal sphincter </li></ul><ul><li>Weakness of external anal sphincter only </li></ul><ul><li>Weakness of puborectalis muscle </li></ul><ul><li>Decreased perception of rectal sensation </li></ul>
  5. 5. Internal anal sphincter <ul><li>Provides most of the resting anal tone </li></ul><ul><li>Main muscle to prevent faecal leakage </li></ul><ul><li>Causes of IAS damage - primary idiopathic degeneration - at childbirth - during anal surgery - secondary to other tissue disorders such as scleroderma </li></ul>
  6. 7. Treatment options for damaged IAS <ul><li>Direct surgical repair of IAS (normal IAS: 2.4-3.4 mm thick) and held at constant basal tension (not beneficial in long term) </li></ul><ul><li>Dynamic graciloplasty/implantation of artificial bowel sphincter (good results but high complication and failure rate) </li></ul><ul><li>Sacral nerve stimulation - electrical stimulation of sacral nerve roots can restore continence in patients with structurally intact muscles - less invasive but experience still limited </li></ul><ul><li>Silicone injection (PTQ ™ implant) </li></ul>
  7. 8. PTQ ™ <ul><li>PTQ  1,10-phenanthroline-5,6-dione </li></ul><ul><li>Silicone implant comprises medical-grade vulcanized silicone particles which are ductile and of irregular texture </li></ul><ul><li>These are suspended in hydrogel low molecular weight, water soluble polyvinylpyrrolidone (povidone, PVP) carrier vehicle which is eliminated by the reticuloendothelial system and excreted through the kidney unchanged </li></ul><ul><li>Mechanism of action of PTQ ™ still unclear </li></ul><ul><li>It is presumed to exert a “padding effect” in the submucosal plane to promote anal closure </li></ul><ul><li>May be the next choice of treatment as numerous studies have demonstrated </li></ul>
  8. 9. Contraindications of PTQ ™ <ul><li>Rectal prolapse </li></ul><ul><li>Faecal impaction </li></ul><ul><li>Symptomatic haemorrhoids </li></ul><ul><li>Perianal and anal scarring </li></ul><ul><li>Perianal sepsis </li></ul><ul><li>Parasitic infection (threadworms) </li></ul><ul><li>Congenital anal sphincter defect </li></ul><ul><li>Uncontrolled diabetes </li></ul><ul><li>Immunosuppression </li></ul><ul><li>Acute inflammation, infection or malignancy </li></ul><ul><li>Pregnancy or within one year postpartum </li></ul><ul><li>Within 12 weeks of another PTQ implant treatment </li></ul>
  9. 10.                    Standard PTQ treatment includes three 2.5 ml PTQ implants and one implantation needle to provide product for trans-dermal augmentation at multiple sites within the internal anal sphincter
  10. 11. Before the procedure <ul><li>Antiplatelet therapy ceased for minimum of 7 days before injection </li></ul><ul><li>Patient administered with Fleet enema 2 hours before procedure </li></ul><ul><li>All patients receive IV prophylactic antibiotics (Gentamicin 160 mg and Metronidazole 500 mg) </li></ul>
  11. 12. During the procedure <ul><li>Injection performed under local anaesthesia as an outpatient procedure </li></ul><ul><li>Patient is placed in the prone jack-knife position and the area cleaned, including anal canal irrigation with betadine solution </li></ul><ul><li>18 gauge 2.5 inch needle introduced through the skin approximately 2 cm from anal margin </li></ul><ul><li>Needle is advanced above the dentate line guided by a finger anal canal </li></ul><ul><li>Care taken not to penetrate mucosa </li></ul><ul><li>3 injections into submucosal plane of 2.5mL at 3, 7 and 11 o’clock positions without endosonographic surveillance </li></ul><ul><li>Duration of procedure takes around half an hour </li></ul>
  12. 13.                                                                 The Figure shows the PTQ™ implant being injected into the anal sphincter. The operators finger guides the needle, 3 or 4 sites are injected this way
  13. 15. After the procedure <ul><li>Patients observed over 6 hour period to exclude any complication of pain or bleeding </li></ul><ul><li>Discharged with oral antibiotics (Cephalexin 500 mg QDS and Metronidazole 400 mg TDS), laxatives (oral lactulose 15 mL) and oral analgesia (Paracetamol 500 mg) for 1 week </li></ul>
  14. 16. Follow-up <ul><li>Patients who showed improvement: Endoanal ultrasound scans showed PTQ ™ implants within the upper part of anal canal extending up to, and partly beyond, the level of the puborectalis ring </li></ul><ul><li>Patients who did not show improvement: Endoanal ultrasound showed residual PTQ ™ had migrated to lie above the puborectalis muscle so that there was no material remaining within the anal canal </li></ul><ul><li>There were no episodes of leakage or infection </li></ul><ul><li>Some patients complained of pruritus ani during the first weeks after the procedure </li></ul><ul><li>Constipation not encountered </li></ul>
  15. 17. EAS IAS
  16. 18. Improvement of Wexner Continence Scale Before injection: median of 13.05 (range 5-20) 1 month after injection: 4.5 (range 2-7.7) 3 months after injection: 5.06 (range 0-16) 6 months after injection: 5.06 (range 0-16) 1 year after injection: 6.2 (range 0-16) 2 years after injection: 9.4 (range 1-20) Portilla et al
  17. 19. Table 2 The Wexner Score Frequency Type of incontinence Never Rarely Sometimes Usually Always Solid 0 1 2 3 4 Liquid 0 1 2 3 4 Gas 0 1 2 3 4 Wears pad 0 1 2 3 4 Lifestyle alteration 0 1 2 3 4 Never: 0 Rarely: <1/month Sometimes: <1/week, >1/month Usually: <1/day, >1/week Always: >1/day 0  Perfect 20  Complete incontinence
  18. 20. Changes in anal manometry after PTQ ™ injection <ul><li>Kenefick, Vaizey, Malouf et al </li></ul><ul><li>Resting anal pressure: increase to a median of 63% </li></ul><ul><li>Vascular filling of anal cushions normally contribute 15-20% of resting anal pressure  provides a watertight seal at the anal margin </li></ul><ul><li>Bulking effect of silicone injections may be enhancing the action of the naturally occurring anal cushions which provide closure in the gap inside the IAS ring </li></ul>
  19. 21. Effect of PTQ ™ on EAS <ul><li>Squeeze pressure rose to a median of 45% (not significant) </li></ul><ul><li>However, it represented an improvement in EAS function </li></ul><ul><li>Increase in pressure was probably due to physical bulking effect of the 3 injections </li></ul>
  20. 22. Why PTQ ™ not associated with absorptive or migration problems <ul><li>Continuous clinical trials and physiological benefit combined with persistent findings in endoanal US suggest the use of PTQ ™ as a bulking agent will not be associated with problems of migration or absorption experienced with previous bulking techniques </li></ul><ul><li>Animal studies : PVP is excreted over a period of 3 days, leaving non-absorbable non-biodegradable silicone particles. The gel is slowly replaced by a fibrin and protocollagen matrix that surrounds silicone particles which at 6 weeks becomes stabilised with collagen fibres. This forms permanent bulking agent that augments IAS </li></ul>
  21. 23. PTQ ™ in patients post haemorrhoidectomy <ul><li>Chan and Tjandra </li></ul><ul><li>Carried out PTQ ™ injection for patients with passive faecal incontinence post haemorrhoidectomy </li></ul><ul><li>Procedure similar except it was carried out under endoanal ultrasound guidance with 25 gauge hypodermic needles inserted into the intersphincteric space and IAS defects in the upper anal canal just below puborectalis ring </li></ul><ul><li>Then, an 18 gauge, 2.5 inch needle with a ratchet gun was inserted through the perianal skin at a position predetermined by the in situ hypodermic needle. </li></ul><ul><li>With a digit within the anal canal, injection of PTQ ™ is performed </li></ul>
  22. 24. A) Endoanal US showing site of needle injection in intersphinteric space (circle) B) PTQ implant after injection
  24. 26. Future research studies on PTQ ™ <ul><li>Results of perianal PTQ ™ injections for passive faecal incontinence are variable in the long term </li></ul><ul><li>Further studies with longer follow-up and larger numbers are required Maeda, Vaizey, Kamm et al (2007) Conducted their study on 6 patients and follow up of 61 months  small change in incontinence score from 13 to 11 in 5 out of the 6 patients </li></ul><ul><li>Precise technique for implantation and the best location of the implant need to be determined; whether ultrasound guided or not OR submucosal vs interspincteric injection </li></ul>
  25. 27. <ul><li>NJ Kenefick, CJ Vaizey, AJ Malouf, CS Norton, M Marshall and MA Kamm. Injectable silicone biomaterial for faecal incontinence due to internal anal sphincter dysfunction. Gut 2002; 51: 225-228 </li></ul><ul><li>F. de la Portilla, A. Fernandez, E. Leon, R. Rada, N. Cisneros, VH Maldonado, J. Vega, E. Espinosa (2008) Evaluation of the use of PTQ ™ implants for the treatment of incontinent patients due to internal anal sphincter dysfunction. Colorectal Disease 10 (1), 89-04 </li></ul><ul><li>UpToDate. Kristen Robson, Anthony J Lembo, Nicholas J Talley, Peter AL Bonis. Updated Feb 6, 2008 </li></ul><ul><li>Chan, M.K., & Tjandra, J.J. (2006). Injectable silicone biomaterial (PTQ) to treat fecal incontinence after hemorrhoidectomy. Dis Colon Rectum, 49 (4), 433-439. </li></ul><ul><li>Maeda, Y., Vaizey, C.J., & Kamm, M.A. (2007). Long-term results of perianal silicone injection for faecal incontinence. Colorectal Dis, 9 (4), 357-361. </li></ul><ul><li>Uroplasty.com </li></ul>References