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Fibrin glue for Anal Fistulae. Bruce D. George, John Radcliffe Hospital, Oxford. Traditional treatment of anal fistula. Seton in high ano-vaginal fistula. Prior to anal fistula surgery. 38 consecutive patients undergoing EUA All pre-op physiology and ultrasound
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Fibrin glue for Anal Fistulae Bruce D. George, John Radcliffe Hospital, Oxford
38 consecutive patients undergoing EUA All pre-op physiology and ultrasound Surgeon blinded to results at time of EUA Surgeon shown results in theatre Surgical management affected in 7 (29% of fistulae) 2 occult sphincter defect 3 reclassification of fistula 2 identification of fistula Colorectal Disease 2002 4 118-22. Influence of anal ultrasound on management of anal fistula
Fibrin Glue Simple Repeatable No wound less pain no scarring Sphincter mechanism undisturbed Other treatment options still available Early return to normal activities
1914-18 1944 Facilitate skin grafting 1970 Commercially available fibrin in Europe 1990 Lange et al GI fistulae 1991 Hjortrup et al Perineal sinus 1993 Abel et al autologous glue for anal fistulae 1998 FDA approval
Fibrin Glue for Anal Fistulae Abel 1993 2/5 40% Venkatesh 1993 12/21 57% Aitola 1999 1/10 10% Citron 1999 50/85 59% Patrlj 2000 51/69 74% El-Shobaky 2000 24/30 80% Sentovich 2001 17/20 85% Total 157/240 65%
Trial of Fibrin Glue for Anal Fistulae Pre-operative assessment clinical anorectal physiology and ultrasound continence score Operative assessment 2 groups: happy to lay open (Simple) not happy to lay open (High/complex)
Trial of Fibrin Glue for Anal Fistulae Intra-operative randomisation to fibrin glue or “conventional” treatment Follow-up (median 17 months, range 6-21) Primary end-points: healing and patient satisfaction Secondary end points: continence scores,anorectal physiology, pain scores, return to normal activities.
Simple Fistulae 6 fibrin glue 3 healed 7 fistulotomy 7 healed p=0.06 Fistulotomy group more satisfied No difference/change in pain scores, continence scores, physiology or return to normal activities
Complex Fistulae 13 Fibrin glue 9 healed 16 “conventional” 2 healed p=0.006 (13 loose seton, 3 advancement flap) Satisfaction scores greater in fibrin glue group Continence scores worse in conventional group No difference in pain scores, physiology or return to normal activities
Perianal abscess 1 patient Complications of Fibrin Glue treatment
Trial patients 12/19 healed 63% Post trial 9/10 healed 90% Overall 21/29 72% Summary of Oxford results
Simple Fistulae Fistulotomy is superior to fibrin glue treatment High/complex Fistulae Fibrin glue treatment may be superior to conventional therapy Conclusions
Unfavourable factors for fibrin glue Short, wide, straight fistula (eg rectovaginal) Sepsis Poor healing (radiotherapy, Crohn’s) Poor technique of glue delivery
Other considerations Risk of transmitting infection human (pooled) fibrinogen viral risks bovine thrombin prion risk allergic
Multicentre trial of Fibrin glue in high/complex fistula versus advancement flap repair Probably just another club in the bag The Place of Fibrin Glue for Anal Fistula