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

Islamabad Medical and Dental College90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anal Fissure Chronic

Interventions

Botulinum Toxin Type A (BOTOX) InjectionDRUG

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.

Lateral Internal SphincterotomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 \-

Outcomes

Primary Outcomes

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.

Time frame: 3 months for healing after intervention