Fistula in ano Therapeutic Options in High Anal Fistulas A. Herold End- und Dickdarmzentrum Mannheim

„Standard Treatment“ of high fistulas subanodermal intersphincteric Fistulectomie distal transsphincteric prox. transsphincteric suprasphincteric Flap procedure extrasphincteric

Flap procedure

Mucosal - flap: Results (1) Type n Persistence Recurrence Transsph. 189 9 % 17 % Suprasph. 35 20 % 37 % Rectovag. 10 33 % 40 % Recurrent f. 21 38 % 47 % Crohn`s f. 29 28 % 48 % Athanasiadis S (1995): Int J Colorect Dis S. 153

Mucosal - flap: Results (1) Type n Persistence Recurrence Healing Transsph. 189 9 % 17 % 74 % Suprasph. 35 20 % 37 % 43 % Rectovag. 10 33 % 40 % 37 % Recurrent f. 21 38 % 47 % 15 % Crohn`s f. 29 28 % 48 % 24 % Athanasiadis S (1995): Int J Colorect Dis S. 153

Mucosal - flap: Results (2) Author Year n Type Rec „Incont“ Williams 91 13 mixed 0 % 62 % Garcia-Aguilar 85 151 mixed 2 % 10 % Wedell 87 30 trans 3 % 0 % Girona 87 96 trans/supra 3/8 % 8/19 % Oh 93 15 mixed 13 % - EDZ 03 41 trans 10 % 0 % Athanasiadis 94 189 trans 20 % 21 % Athanasiadis 83 81 mixed 21 % - Schouten 99 44 trans 25 % - Jones 87 39 trans 31 % - Gustafsson 02 42 trans 45 % 11 % Baeten 05 41 mixed 63 % (3Ja.) 17 %

EDZ - Results (transsphincteric) n = 88, 04/2001 – 04/2004, Follow up: 35 mo (18 - 60 mo), 18% recurrent, 12% horse shoe, without Crohn´s, Transsphincteric: n = 41 Total Healing: n = 35 (85 %) Primary Healing: n = 27 (66 %)

EDZ - Results (transsphincteric) n = 88, 04/2001 – 04/2004, Follow up: 35 mo (18 - 60 mo), 18% recurrent, 12% horse shoe, without Crohn´s, Transsphincteric: n = 41 Total Healing: n = 35 (85 %) Primary Healing: n = 27 (66 %) Persistence: n = 10 (24 %) Recurrence: n = 4 (10 %) Re-Flap healed: n = 2 Fistulectomy: n = 5 Excision + Reconst: n = 1 Still persisting: n = 6 Total Healing Rate with Flap: 71 % (Incontinent: 0%)

Treatment Alternatives Anal Fistula Plug Fibrine Glue Fistulectomy and secondary repair primary repair Longterm – Seton

Anal - Fistula - Plug (AFP) Surgisis Anal Fistula Plug

AFP - Procedure

AFP: First Prospective Trial n = 25 Pat. (transsphincteric Fistulas), kryptoglandular, FU: 13 wks. n Healing Fibrine 10 40 % Plug 15 87 % 9 Johnson E, Armstrong D (USA): Dis Colon Rectum 2006 S. 371

AFP: Prospective Trial n = 20 Pat. (36 transsphincteric Fistulae), Crohn`s Disease, FU: 10 Mo. (3 – 24) n Healing Simple Fistula 13 100 % Komplex Fistula 7 45 % Total 20 80 % 9 O`Connor L, Armstrong D (USA): Dis Colon Rectum 2006 S. 1569

Anal Fistula Plug: Results (USA) Author Year n FU Healing Robb (ASCRS 2004) 04 17 12 Mo Champagne (Armstrong) 06 46 12 Mo Poirier (Abcarian) 06 28 3 Mo Ky (New York) 07 42 3 Mo Christoforidis (Mineapolis) 07 57 3 Mo Cintron (USA) 07 28 3 Mo Abbas (Efron LA) 07 17 7 Mo Safar (Wexner) 07 39 4 Mo

Anal Fistula Plug: Results (USA) Author Year n FU Healing Robb (ASCRS 2004) 04 17 12 Mo 65 % Champagne (Armstrong) 06 46 12 Mo 83 % Poirier (Abcarian) 06 28 3 Mo 54 % Ky (New York) 07 42 3 Mo 81 % Christoforidis (Mineapolis) 07 57 3 Mo 40 % Cintron (USA) 07 28 3 Mo 54 % Abbas (Efron LA) 07 17 7 Mo 24 % Safar (Wexner) 07 39 4 Mo 14 %

Anal Fistula Plug: Results (Europe) Author Year n FU Healing Lenisa (I) 07 27 8 Mo 85 % Van Koperen (NL) 07 17 7 Mo 41 % Garg (Ind) 07 27 6 Mo 66 % Bohe (Sw) 07 32 6 Mo 66 % Thekkinkattil (UK) 07 38 6 Mo 39 % AFP-Workshop 07 15-25 < 6 Mo 41-70 %

Anal Fistula Plug: Results Germany (Follow up 6 Mo.) Author n FU Healing Schwandner (Gießen) 60 trans. Soetje (Wiesbaden) 59 trans. Scherer (Berlin) 25 Ftr/Fsu Schwandner (Regensburg) 19 trans. Herold (Mannheim) 18 trans Peters (Köln) 13 trans. Kolbus (Leipzig) 7 trans. Pakravan (Düsseldorf) 6 trans

Anal Fistula Plug: Results Germany (Follow up 6 Mo.) Author n FU Healing Schwandner (Gießen) 60 trans. 63 % Soetje (Wiesbaden) 59 trans. 74 % Scherer (Berlin) 25 Ftr/Fsu 48 % Schwandner (Regensburg) 19 trans. 61 % Herold (Mannheim) 18 trans 39 % Peters (Köln) 13 trans. 38 % Kolbus (Leipzig) 7 trans 85 % Pakravan (Düsseldorf) 6 trans 66 %

Treatment Alternatives Anal Fistula Plug Fibrine Glue Fistulectomy and secondary repair primary repair Longterm – Seton Author Year n FU Healing Abel (USA) 93 6 7 Mo 75 % Cintron (USA) 00 53 12 Mo 72 % Patrlj (Yug) 00 30 28 Mo 70 % Lindsey (GB) 02 17 17 Mo 43 % Chan (GB) 02 10 6 Mo 60 % Sentovich (USA) 03 36 22 Mo 69 % Zmora (USA) 03 10 12 Mo 33 % Buchanan (GB) 03 16 14 Mo 16 % Loungnarath (USA) 04 22 < 26 Mo 23 %

Treatment Alternatives Anal Fistula Plug Fibrine Glue Fistulectomy and secondary repair primary repair Longterm – Seton

Fistulectomy and Secondary Repair

Secondary Repair: Results Author Year n Success Keighley (GB) 83 19 61 % Browning (GB) 84 97 78 % Fang (USA) 84 79 89 % Christiansen (DK) 87 23 60 % Laurberg (USA) 88 19 47 % Ctercteko (USA) 88 58 64 % Yoshioka (GB) 89 27 74 % Jacobs (NL) 90 37 83 % Fleshman (USA) 91 55 51 % Wexner (USA) 91 16 76 % Arnaud (F) 91 40 63 % Engel (NL) 94 55 76 % Oliveira (USA) 96 55 71 % Mölle (CH) 97 33 74 % Halverson (USA) 01 45 41 % EDZ (D) 04 32 87 % Total: 35 Studies: Success rate 75 % (41 – 89 %)

Treatment Alternatives Anal Fistula Plug Fibrine Glue Fistulectomy and secondary repair primary repair Longterm – Seton

Fistulectomy and Primary Repair

Fistulectomy and Primary Repair (2): Episioproctectomy

Primary Repair: Results Author Year n Type Dehiscence Recurr. Incontinence Parakash (Ind) 85 120 distal - 2,5 % - Lux (D) 91 46 mixed 0 0% 20 % (1+2°) Christiansen (DK) 95 14 mixed - 15 % 21% (1+2°) Gemsenjäger (CH) 96 21 mixed 5 % 5 % 5 % Lewis (GB) 96 32 mixed - 9,5 % Roig (E) 99 31 mixed 4 % 10 % 24% (1+2°) Perez (E) 05 35 mixed - 6 % 12 % Herold (D) 05 34 mixed 8% (14%) 6 % - Perez (E) 06 16 mixed 0 6 % (improved) Herold (D) 06 84 mixed 5% (11%) 6 % no 3°

Primary Repair: Results correlated with involved Sphincter (1) 2 3

√ √ Primary Repair: Results correlated with involved Sphincter (2) Dehiscence: 0% - 20% Recurrence: 20% - 50% √ 2,5% √ 4 %

EDZ - Results (preliminary) n = 148, 11/2004 – 10/2007, Follow up: 20 mo (12 - 48 mo) Total: n = 120 Total Healing: n = 114 (94%) Primary Healing: n = 95 (79%) Re-Rekonstruktion: n = 6 Healing (1 Stoma): n = 4 Persisting Fistula: n = 2 Dehiscence: n = 6 ( 5%) Recurrence: n = 19 (16%) Re-Do: n = 19 Fistulectomy : n = 12 Persisting Fistula: n = 4 Rekonstruktion: n = 3(2) Total Healing Rate with Primary Reconstruction: 84 %

Treatment Alternatives Anal Fistula Plug Fibrine Glue Fistulectomy and secondary repair primary repair Longterm – Seton

Conclusion: 40% (15 – 85%) Anal Fistula Plug Flap-Procedure Healing Rate Anal Fistula Plug 40% (15 – 85%) Flap-Procedure 70% (50 – 80%) Fistulectomy with secondary Sphincter Reconstruction > 95% Fistulectomy with primary 90% (80 – 95%) Fibrine Glue 15% (10 – 70%) Longterm – Seton 0%

Conclusion: 40% (15 – 85%) Anal Fistula Plug 0% Flap-Procedure Healing Rate Incontinence (2° + 3°) Anal Fistula Plug 40% (15 – 85%) 0% Flap-Procedure 70% (50 – 80%) < 10% Fistulectomy with secondary Sphincter Reconstruction > 95% 20 – 50% Fistulectomy with primary 90% (80 – 95%) < 20% Fibrine Glue 15% (10 – 70%) Longterm – Seton --

….. but we are far from perfect ! Summary We are on the way ……. ….. but we are far from perfect !