EP308 - Ksharsutra Treatment in Complex Fistula-in-Ano: A 1150-Patient Study Demonstrating Anatomical Preservation and Continence Safety

Purpose/Background: Complex fistula-in-ano presents persistent challenges due to its high recurrence and risk of incontinence after conventional procedures like fistulotomy, fistulectomy, and advancement flap repair. The Ksharsutra technique, described by Sushruta over 3000 years ago, provides a minimally invasive, sphincter-sparing alternative. The medicated seton, made from Apamarga Kshara (Achyranthes aspera), Snuhi Ksheera (Euphorbia neriifolia latex), and Haridra (Curcuma longa), enables controlled chemical cutting, drainage, and healing while preserving continence. This prospective study evaluates the safety, efficacy, recurrence, and continence outcomes of Ksharsutra therapy in complex fistula-in-ano

Methods/Interventions: A prospective interventional study was conducted at a tertiary Ayurvedic Proctology center between January 2017 and December 2024. 1150 patients (748 males, 65.0%; 402 females, 35.0%) aged 18-74 years (mean 41.2 ± 9.1) were included. Cases comprised complex,high trans-sphincteric, trans-sphincteric with high intersphincteric or supralevator extension's , and recurrent fistulas. Patients with Crohn's, tuberculosis, malignancy, or immunosuppression were excluded.

Under saddle block anesthesia:

1. Internal and external openings identified by probing and methylene blue instillations.

2. Tract delineated along the primary path.

3. Fistula tract excised from the external opening up to the level it pierces the external anal sphincter (EAS) to improve drainage while preserving sphincter integrity.

4. Ksharsutra placed through the remaining sphincter-bearing segment (EAS to internal opening) and tied with moderate tension

5. Weekly thread changes until complete cut-through and healing

Postoperative care included sitz baths, high-fiber diet, and local Jatyadi Taila dressing. Follow-up continued for one year post-healing. Statistical analysis used SPSS v24, p < 0.05 significant

Results/Outcomes: Of 1150 cases, 598 (52%) were high trans-sphincteric, 345 (30%) trans-sphincteric with inter-sphincteric extension, and 207 (18%) transphincteric with intersphincteric and supralevator high extension.Recurrent fistulas comprised 115 (10%) cases. Internal openings were posterior midline in 828 (72%) and anterior midline in 322 (28%).

Complete healing occurred in 1087 (94.5%). Mean duration of Ksharsutra therapy was 9.1 ± 2.6 weeks (range 6-13), with supralevator tracts requiring longer (11.7 weeks; p < 0.01). Healing was complete within 8-10 weeks in 90% of cases. Recurrence occurred in 18 (1.6%) patients, 9 of whom belonged to the trans-sphincteric with intersphincteric and supralevator extension group. Mild flatus incontinence (Wexner ≤ 2) occurred in 68 (5.9%) patients; no liquid or solid stool incontinence was noted

Conclusion/Discussion: Ksharsutra therapy provides a safe, effective, and sphincter-preserving approach for managing complex and recurrent fistula-in-ano. The additional step of excising the tract up to the external sphincter enhances drainage and healing while maintaining continence. With a 94.5% success rate, only 1.6% recurrence, and no major incontinence, this ancient Ayurvedic technique represents a validated, minimally invasive solution aligning traditional principles with modern sphincter-sparing surgical goal's.

Ksharsutra treatment in complex fistula -in -Ano
Fistula-in-ano with External opening at base of penis
Ksharsutra Treatment in Complex Fistula in Ano
Ksharsutra placement in fistula track

1}from external opening to created window by intercepting tract at peri anal area

2)from internal opening to created window by intercepting tract at perianal area.