Evidence map›Paper›PMID 42287321›Full record

ArticleTechniques in coloproctology2026

Efficacy of botulinum toxin type A administration within the current therapeutic algorithm for chronic anal fissure: study protocol for the prospective multicentre observational study FISURBOT-GECO6.

Nuria Ortega-Torrecilla, Jorge Arredondo, Franco Marinello, Maria Luisa Reyes-Diaz, Carlos Cerdán, Oscar Cano-Valderrama, Tamara Fernández, Lidia Cristóbal, Teresa Calderón, Beatriz Martín-Pérez

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Article in Techniques in coloproctology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Nuria Ortega-TorrecillaDepartment of Surgery, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.
Jorge ArredondoDepartment of Surgery, Clínica Universidad de Navarra. Av, Pío XII 36, 31008, Pamplona, Navarra, Spain. jarredon@unav.es.ORCID http://orcid.org/0000-0001-8077-6092
Franco MarinelloDepartment of Surgery, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.
Maria Luisa Reyes-DiazDepartment of Surgery, Hospital Virgen del Rocío, Sevilla, Spain.
Carlos CerdánDepartment of Surgery, Hospital Universitario de La Princesa, Madrid, Spain.
Oscar Cano-ValderramaDepartment of Surgery, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
Tamara FernándezDepartment of Surgery, Hospital Galdakao-Usansolo, Bilbao, Spain.
Lidia CristóbalDepartment of Surgery, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
Teresa CalderónDepartment of Surgery, Hospital General Universitario Nuestra Señora del Prado, Talavera de La Reina, Spain.
Beatriz Martín-PérezDepartment of Surgery, Complejo Hospitalario Universitario de Badajoz, Badajoz, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic anal fissure is a common, benign anorectal condition associated with impaired quality of life. Despite the availability of several therapeutic options, considerable variability persists in its management, particularly regarding the role of botulinum toxin type A administration within the current treatment algorithms. Although botulinum toxin type A injection is a widely used approach to achieve chemical sphincterotomy, its real-world efficacy and safety across different clinical scenarios remain insufficiently characterised.

aimOur objective is to evaluate the efficacy and safety of botulinum toxin type A injection for the treatment of chronic anal fissure after failure of topical therapy or lateral internal sphincterotomy in routine clinical practice settings by analysing the healing rate, continence outcomes and the need for subsequent surgical intervention in predefined clinical scenarios.

methodsFISURBOT-GECO6 (0143-2024-OBS) is a national, multicentre, prospective, pragmatic observational study. Consecutive patients with chronic anal fissure in whom botulinum toxin treatment is recommended according to routine clinical practice are eligible. Patients will be classified into three clinical scenarios: (1) chronic anal fissure with sphincter hypertonia and no risk factors for anal incontinence after failure of topical therapy; (2) chronic anal fissure with recognised risk factors for anal incontinence after failure of topical therapy; and (3) chronic anal fissure persisting or recurring at least 12 weeks after lateral internal sphincterotomy. Botulinum toxin type A administered at a dose of 50 or 100 IU, according to routine practice. Patients will be evaluated at 1, 3 and 12 months after treatment. The primary outcome is clinical healing. Secondary outcomes are anal continence, procedure-related morbidity, need for repeat treatment or surgery and patient satisfaction. EXPECTED RELEVANCE: This study will provide prospective, real-world data on the efficacy and safety of botulinum toxin type A injection for chronic anal fissure management in clinically relevant scenarios. The results are expected to help clarify the role of this approach within current therapeutic algorithms and inform clinical decision-making in daily practice. TRIAL SPONSOR: Spanish Society of Coloproctology (AECP).

Indexed as

Botulinum Toxins, Type AFissure in AnoNeuromuscular AgentsAdultAlgorithmsAnal CanalChronic DiseaseFemaleHumansMaleMulticenter Studies as TopicObservational Studies as TopicProspective StudiesTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsAnal fissureBotoxBotulinum toxin

Identifiers

PMID42287321
PMCPMC13490238

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.