Fistula-in-ano: a probing of the treatment options David Jayne Professor of Surgery University of Leeds & Leeds Teaching Hospitals NHS Trust John Goligher Colorectal Unit

The Problem

Aetiology Cryptoglandular Crohn’s disease Other Malignant Obstetric Radiation

Classification 45% 30% 20% 5%

Goodsall’s Rule

Treatment Aims Eradicate disease (if possible) Preservation of continence Benign condition Quality of life

Principles Control sepsis Define anatomy Exclude co-existent disease EUA Laying open abscesses and secondary tracts Adequate drainage – seton insertion Define anatomy Openings and tracts Internal and External Single –v- multiple Extensions / Horseshoe Relation to sphincter complex High –v- Low Exclude co-existent disease

MRI for fistula-in-ano Abscesses & Extensions Contralateral disease Other pathology HALLIGAN Radiology 2006

Surgical Options – Fistulotomy Fistula tract identified with probe Extent of external sphincter involvement assessed Tract and muscle divided Secondary tracts laid open +/- marsupialisation wound

Surgical Options – Cutting Seton Lay open external tract Draining seton replaced with cutting seton 1/0 Prolene suture Tied tight around sphincter complex Simultaneous slow cutting and repair of sphincter May require re-tightening

Surgical Options – Fistulectomy Draining seton Core out tract Direct visualisation of secondary tracts Sphincter repair +/- advancement flap

Advancement Flaps Endorectal Fistula tract probed Flap raised Mucosa + Int. Sphincter Internal opening excised/closed Flap advanced & sutured

Advancement Flap Anodermal Fistula tract probed Flap raised Flap advanced & sutures External defect closed

Fistula Plug

Fistula Plug

LIFT Procedure Ligation of Intersphincteric Fistula Tract Transsphincteric fistula Draining seton – 6 weeks Tract prepared with fistula brush Debrides De-epithelializes

LIFT Procedure

PROS CONS Cutting Seton Simple Cheap Repeat EUA Recurrence 0 – 8% Incontinence minor 34 – 63% major 2 – 26% Fistulotomy Recurrence 2 – 9% Incontinence 50% Advancement Flap Can be difficult ?Preserves sphincter Recurrence 25 – 50% Incontinence 30 – 35% Fistula Plug Preserves sphincter Plug expensive ~£400 Recurrence 20 – 85% Continence preserved LIFT Recurrence 15 - 40%

ACPGBI FIAT Trial Fistula Plug Insertion Surgeon’s Preference EUA: transsphincteric fistula ≥ 1/3 of sphincter complex Insertion of draining seton RANDOMISE MRI fistulography Advancement Flap Cutting Seton Fistulotomy LIFT

ACPGB&I FIAT Primary end-points Faecal incontinence QoL Generic QoL Patient identification EUA & draining seton Eligibility & Consent Randomisation 1:1 plug –v- surgeon’s preference 6-week FU 6-monthFU 12-month FU + MRI scan Surgisis® fistula plug Surgeon’s preference (fistulotomy, seton, advancement flap, LIFT) MRI scan Surgery (6-weeks post seton insertion) Primary end-points Faecal incontinence QoL Generic QoL Secondary end-points Healing – 12 months Complications Faecal incontinence Re-interventions Health resource utilisation Cost effectiveness

FIAT FACTS Recruitment: 76 Target: 500 Open centres: 36 Recruiting centres: 21

Join the FIAT Trial!

Fistula-in-ano: a probing of the treatment options David Jayne Professor of Surgery University of Leeds & Leeds Teaching Hospitals NHS Trust John Goligher Colorectal Unit