Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial
Cryptoglandular perianal fistula with at least 2 previous documented surgical failures
Parks classification: intersphincteric or transsphincteric (low or high)
Seton drain in situ for a minimum of 6 months at the time of surgery
No active perianal sepsis (no purulent discharge, abscess or cellulitis)
Crohn's disease or ulcerative colitis
Suprasphincteric or horseshoe fistula
Active perianal abscess or sepsis at the time of surgery
Secondary fistula tracts on endoanal ultrasound
Single group
Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients
Procedure/SurgeryPerilesional injection of 7 ml of autologous platelet-rich growth factor (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain), prepared from 36 ml of peripheral venous blood collected in four 9-ml sodium citrate tubes, centrifuged at 580 rpm for 8 minutes. The platelet-rich fraction, free of leucocytes and erythrocytes, is activated with autologous calcium chloride solution (0.05 ml of CaCl₂ 10% per ml of PRGF) immediately before injection and administered perilesionally around the fistula tract and internal opening closure site using a 23-gauge needle under direct vision.
Measure: Clinical cure at 12 months
Complete closure of the external opening without spontaneous or compression-induced drainage on clinical examination
Incidence of Postoperative Complications Classified by Clavien-Dindo Grade [Safety]
Any postoperative complication within 30 days classified by Clavien-Dindo system: Grade I = minor deviation requiring no treatment; Grade II = pharmacological treatment; Grade III = surgical/endoscopic/radiological intervention; Grade IV = organ dysfunction; Grade V = death). Proportion with Grade III or above reported separately.
Clinical cure at 6 months
Complete closure of the external opening without spontaneous or compression-induced drainage on clinical examination at 6 months after the procedure.
Change in Faecal Continence Assessed by Wexner Continence Grading Scale
Wexner Continence Grading Scale (range 0-20; 0 = perfect continence, 20 = complete incontinence; lower scores indicate better continence). Change from baseline to each timepoint reported.
Postoperative Pain Assessed by Visual Analogue Scale
Visual Analogue Scale for pain (range 0-10 cm; 0 = no pain, 10 = worst imaginable pain; lower scores indicate less pain)..
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