Is chemodenervation with incobotulinumtoxinA an alternative to invasive chronic anal fissure treatments?

Autor: Calderón T; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain. ttcd01@gmail.com., Arriero L; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain., Cruz P; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain., Gómez L; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain., Asanza J; Servicio de Cirugía General y Aparato Digestivo, Hospital Universitario de Guadalajara, Guadalajara, Castilla-La Mancha, Spain., Santiago JC; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain., Garrido R; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain., Bustamante C; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain., Balsa T; Servicio de Cirugía General y Aparato Digestivo, Hospital Nuestra Señora del Prado. Talavera de La Reina, Toledo, Spain.
Jazyk: angličtina
Zdroj: BMC gastroenterology [BMC Gastroenterol] 2024 Sep 30; Vol. 24 (1), pp. 334. Date of Electronic Publication: 2024 Sep 30.
DOI: 10.1186/s12876-024-03428-z
Abstrakt: Background: Botulinum toxin type A is currently strongly recommended for the treatment of anal fissures (AFs). However, there is still no consensus on dosage or injection technique. This study provides further efficacy and safety evidence in a 2-year follow-up.
Method: Prospective, open-label, single-arm, single-center study carried out in adult patients with AFs non-responsive to previous treatments. Patients were treated with incobotulinumtoxinA (incoBoNT/A) injected in both laterals and posterior intersphincteric groove. Healing rate at 2 years was the primary endpoint. Secondary endpoints included internal anal sphincter pressures, incontinence, and safety.
Results: A total of 49 patients were treated with a mean incoBoNT/A dose of 40.5 U (spread across three locations). Healing rate at 2 years was 83.9% with a 24.5% of recurrence throughout the study. Only 7 patients (14.3%) reported adverse events (AEs) that were mild and temporary. Mean reduction in anal resting pressure was -9.1 mmHg at 3 months (p = 0.001). Mean reduction in voluntary squeeze pressure was -27.5 mmHg at 3 months (p < 0.001). Mean pain perception measured with a visual analog scale decreased by -6.5 points at 2 years (p < 0.001). There was an incontinence increase at 1 month of 1.3 points (p = 0.006), but baseline values were restored at 6 months.
Conclusion: We present results that support the use of incoBoNT/A as a second line for AFs that do not respond to ointment therapy. IncoBoNT/A injection is a less invasive treatment that should be considered before surgery due to its efficacy and its safety which includes no permanent impairment.
Trial Registration: ISRCTN90354265; Registered on 16th February 2024. Retrospectively registered.
(© 2024. The Author(s).)
Databáze: MEDLINE
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