Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure

Official title

Comparative Outcomes of Injection Botox Alone Versus Injection Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure

Overview

Chronic anal fissure is a common benign anorectal condition characterized by severe pain during defecation, rectal bleeding, and reduced quality of life. Injection Botox is a widely used sphincter-preserving treatment that produces temporary relaxation of the internal anal sphincter and promotes fissure healing. However, healing rates with injection Botox alone are variable and recurrence remains a concern. This prospective comparative trial aims to compare the effectiveness and safety of injection Botox alone versus injection Botox combined with fissurectomy and anoplasty in adults with chronic anal fissure. The study will evaluate healing rate, pain relief, time to healing, recurrence, postoperative complications, continence outcomes, and patient satisfaction. A total of 108 eligible patients with chronic anal fissure will be enrolled and allocated to one of the two treatment groups. Participants will be followed after treatment to assess clinical outcomes. The results of this study are expected to provide evidence regarding the optimal sphincter-preserving treatment approach for chronic anal fissure and help improve patient care and quality of life.

Detailed description

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.

Interventions

• Drug Botulinum Toxin Type A (BOTOX) Injection
  Botulinum toxin type A will be administered as a 30 IU injection into the internal anal sphincter under appropriate anesthesia. The dose will be divided equally between the 3 o'clock and 9 o'clock positions (15 IU at each site) to produce temporary chemical sphincterotomy and reduce sphincter hypertonia associated with chronic anal fissure.
• Procedure Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty
  Following injection Botox, fissurectomy will be performed by excising the fibrotic edges of the chronic anal fissure, sentinel skin tag, and hypertrophied anal papilla when present until healthy vascularized tissue is exposed. Advancement flap anoplasty will then be performed by mobilizing a well-vascularized anodermal or cutaneous flap and advancing it to cover the defect without tension. The flap will be secured using absorbable sutures.

Primary outcome measures

• Fissure Healing Rate [Time frame: 3 Months After Treatment for primary outcome in terms of chronic anal fissure healing]

Eligibility criteria

Inclusion criteria

Adults aged 18 to 65 years, regardless of sex Diagnosis of chronic anal fissure persisting for more than 6 weeks Failure of at least 6 weeks of standardized conservative treatment Fit for anesthesia and surgical intervention Willing and able to provide written informed consent

Exclusion criteria

Acute anal fissure Inflammatory bowel disease Anal malignancy Previous anal surgery Pregnancy Pre-existing fecal incontinence Immunocompromised patients

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: NCT07665528 · IMDC-CRS-CAF-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗