Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management

Официальное название

A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure

Обзор

This study aims to compare two commonly used treatments for chronic anal fissure: botulinum toxin injection and lateral internal sphincterotomy. Chronic anal fissure is a painful condition that causes severe discomfort during bowel movements and can significantly affect a patient's quality of life. Botulinum toxin injection is a minimally invasive procedure that temporarily relaxes the anal sphincter muscle to promote healing. In contrast, lateral internal sphincterotomy is a minor surgical procedure that permanently reduces sphincter pressure and is considered the standard treatment with high healing rates. A total of 90 adult patients with chronic anal fissure will be enrolled and divided into two groups. One group will receive botulinum toxin injection, while the other group will undergo lateral internal sphincterotomy. Patients will be followed up regularly to assess healing, pain relief, recurrence of the fissure, and any complications such as incontinence. The purpose of this study is to determine which treatment provides better outcomes in terms of effectiveness and safety, helping doctors choose the most appropriate treatment for patients.

Вмешательства

• Препарат Botulinum Toxin Type A (BOTOX) Injection
  A total dose of 20 units of botulinum toxin type A will be administered via intrasphincteric injection. The toxin will be diluted in 1 ml of normal saline and injected into the internal anal sphincter in two equal doses of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane using a 26-30 gauge needle under aseptic conditions.
• Процедура Lateral Internal Sphincterotomy
  An open lateral internal sphincterotomy will be performed under spinal anesthesia. A small lateral incision will be made at the 3 o'clock position, and the lower one-third of the internal anal sphincter will be divided under direct vision. Hemostasis will be achieved, and the wound will be left open to heal by secondary intention.

Первичные конечные точки

• Proportion of patients with complete fissure healing at 3 months after treatment (Botulinum toxin vs. Lateral Internal Sphincterotomy). This is the main endpoint on which your sample size calculation and comparative effectiveness analysis are based. [Срок оценки: 3 months for healing after intervention]

Критерии участия

Inclusion Criteria:Age 18-65 years Diagnosed chronic anal fissure (>6 weeks duration) Failure of conservative management Both male and female patients Willingness to provide informed consent -

Exclusion Criteria:Acute anal fissure Previous anal surgery Inflammatory bowel disease Pregnancy Neurological disorders affecting continence Known hypersensitivity to botulinum toxin

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Islamabad Medical and Dental College — Islamabad

Идентификаторы

NCT: NCT07568314 · ANTH-GS-CAF-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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