Vol. 2, Issue 2, Part A (2025)

Background: Bhagandara (fistula-in-ano) is a chronic cryptoglandular anorectal disease associated with recurrence and risk of continence disturbance after conventional surgery. Kṣārasūtra therapy, an Ayurvedic para-surgical technique employing a medicated seton, has been proposed as a sphincter-preserving alternative, but comparative data with contemporary surgical practice remain limited.
Objectives: To compare the efficacy, safety and functional outcomes of Kṣārasūtra therapy versus conventional surgery in patients with cryptoglandular Bhagandara (fistula-in-ano).
Methods: In this prospective, randomized, open-label, parallel-group study conducted at a tertiary care teaching hospital, 60 adults with MRI/endoanal ultrasound-confirmed intersphincteric or transsphincteric fistula-in-ano were randomized 1:1 to Kṣārasūtra therapy (Group A) or conventional surgery (fistulectomy/fistulotomy with or without seton; Group B). The Kṣārasūtra was prepared according to classical methods and changed weekly until complete tract cutting and fibrosis. Primary outcomes were complete healing at 12 weeks and recurrence at 6 months. Secondary outcomes included post-operative pain (VAS), time to complete wound healing, duration of hospital stay, days off work, complications, Wexner continence score and change in health-related quality of life at 6 months. Data were analysed using appropriate parametric and non-parametric tests with p<0.05 considered significant.
Results: Baseline demographic and fistula characteristics were comparable between groups. Complete healing at 12 weeks was achieved in 93.3% of patients in Group A and 83.3% in Group B (p=0.27). Recurrence at 6 months was significantly lower with Kṣārasūtra (3.3% vs 20.0%; p=0.046). Early post-operative pain scores were lower in Group A at 24 hours (6.1±1.0 vs 7.2±1.1; p=0.001) and 48 hours (4.8±1.0 vs 5.6±1.2; p=0.02), with no significant difference at 72 hours. Wound-healing time was longer with Kṣārasūtra (44.6±9.3 vs 28.3±7.1 days; p<0.001), but hospital stay (2.1±0.7 vs 4.9±1.4 days; p<0.001) and days off work (11.3±3.8 vs 15.9±4.6; p<0.001) were significantly reduced. At 6 months, Wexner continence scores (0.2±0.6 vs 0.9±1.1; p=0.03) and improvement in quality-of-life scores (+18.5±6.9 vs +14.2±7.4; p=0.02) favoured Kṣārasūtra therapy. Complication rates were low and comparable in both groups.
Conclusion: Kṣārasūtra therapy is at least as effective as conventional surgery for Bhagandara (fistula-in-ano) and offers important advantages in terms of lower recurrence, better continence preservation, shorter hospitalization and earlier return to work, at the cost of a longer overall wound-healing period. When delivered in a standardized, interdisciplinary setting, Kṣārasūtra represents a viable sphincter-preserving primary option for selected cryptoglandular fistulas, and its integration into modern colorectal practice may improve long-term functional and patient-centred outcomes.