Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Botulinum Toxin Type A (BOTOX) Injection, Lateral Internal Sphincterotomy.
- Who it may be relevant to
- Registry conditions: Anal Fissure Chronic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure
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.
Interventions
- Drug 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. - Procedure 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.
Primary outcome measures
- 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]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Islamabad Medical and Dental College — Islamabad
Identifiers
NCT: NCT07568314 · ANTH-GS-CAF-2026