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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Fissure Chronic
• Intervention / Treatment: Drug: Botulinum Toxin Type A (BOTOX) Injection; Procedure: Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Dr. Rizwan Aziz; Phone Number: +923008444229; Email: aziz.rizwan@imdcollege.edu.pk
• Study Contact Backup: Name: Prof. Dr. Asma Irfan; Phone Number: +923215016605; Email: asma.irfan@imdcollege.edu.pk

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Recruiting
      • Islamabad Medical and Dental College
      • Contact: Prof. Dr. Asma Irfan; Phone Number: +923215016605; Email: asma.irfan@imdcollege.edu.pk
      • Contact: Dr. Imtiaz Ahmed Khattak; Phone Number: +923339223185; Email: drimtiazkhattak@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection Botox Alone; Participants in this arm will receive injection of 30 IU botulinum toxin type A into the internal anal sphincter at the 3 and 9 o'clock positions (15 IU at each site). The procedure will be performed under appropriate anesthesia according to the study protocol. Participants will undergo scheduled follow-up assessments for healing, pain relief, recurrence, continence, complications, and patient satisfaction.	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.
Active Comparator: Injection Botox Plus Fissurectomy and Anoplasty; Participants in this arm will receive injection of 30 IU botulinum toxin type A into the internal anal sphincter followed by fissurectomy and advancement flap anoplasty. Fissurectomy will involve excision of the chronic fissure and associated fibrotic tissue, including sentinel skin tag and hypertrophied anal papilla when present. Advancement flap anoplasty will then be performed to cover the defect with well-vascularized tissue. Participants will undergo scheduled follow-up assessments for healing, pain relief, recurrence, continence, complications, and patient satisfaction.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fissure Healing Rate	Proportion of participants achieving complete healing of chronic anal fissure, defined as complete epithelialization of the fissure with absence of anal pain during defecation on clinical examination.	3 Months After Treatment for primary outcome in terms of chronic anal fissure healing

Collaborators and Investigators

• Sponsor: Islamabad Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): December 3, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Drug Administration Routes; Drug Therapy; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; Injections
• Other Study ID Numbers: IMDC-CRS-CAF-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No