Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure (BTX-CAF)

Chronic anal fissure (CAF) is a longitudinal tear in the distal anal canal that persists for more than six weeks and is commonly associated with severe pain during defecation, bleeding per rectum, and impaired quality of life. The pathophysiology of CAF is primarily related to internal anal sphincter hypertonia, reduced anodermal blood flow, and impaired wound healing. Persistent sphincter spasm results in local ischemia, creating a cycle that prevents fissure healing and contributes to chronic symptoms.

Conservative management with dietary modification, stool softeners, topical nitrates, and calcium channel blockers is generally considered first-line therapy. However, these treatments may be limited by side effects, incomplete healing, and recurrence. Injection Botox has emerged as an effective sphincter-preserving alternative by producing temporary chemical sphincterotomy and reducing sphincter pressure. Although associated with a lower risk of permanent fecal incontinence than lateral internal sphincterotomy, reported healing rates with Injection Botox alone remain suboptimal in some patients.

Fissurectomy combined with advancement flap anoplasty is a surgical technique designed to promote healing by removing chronic fibrotic tissue and restoring vascularized tissue coverage of the fissure site. Recent evidence suggests that combining Injection Botox with fissurectomy and anoplasty may improve healing outcomes by addressing both sphincter hypertonia and impaired local perfusion.

The purpose of this prospective comparative trial is to compare the clinical outcomes of Injection Botox alone versus Injection Botox combined with fissurectomy and anoplasty in adult patients with chronic anal fissure. The primary objective is to evaluate fissure healing. Secondary objectives include assessment of pain relief using the Visual Analogue Scale (VAS), time to healing, recurrence within six months, postoperative complications, continence status using the Wexner Incontinence Score, and patient satisfaction.

The study will be conducted in the Department of Colorectal Surgery, Dr. Akbar Niazi Teaching Hospital, Islamabad Medical and Dental College, Islamabad. A total of 108 patients meeting eligibility criteria will be enrolled. Participants will receive either Injection Botox alone or Injection Botox followed by fissurectomy and advancement flap anoplasty. Standardized operative and postoperative protocols will be used. Patients will undergo follow-up assessments at scheduled intervals to evaluate healing and other study outcomes.

The findings of this study are expected to generate local evidence regarding the comparative effectiveness and safety of these sphincter-preserving treatment strategies and may help guide future management of chronic anal fissure.