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

NCT07665528 | Recruiting

• 1 other identifier: IMDC-CRS-CAF-2026-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Fissure Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Injection Botox Alone

EXPERIMENTAL

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

Injection Botox Plus Fissurectomy and Anoplasty

ACTIVE COMPARATOR

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

Interventions

Botulinum Toxin Type A (BOTOX) Injection DRUG

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.

Injection Botox Alone

Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty PROCEDURE

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.

Injection Botox Plus Fissurectomy and Anoplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Islamabad Medical and Dental College

Islamabad, Federal, 44000, Pakistan

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A; Injections

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Prof. Dr. Rizwan Aziz

CONTACT

+923008444229; aziz.rizwan@imdcollege.edu.pk

Prof. Dr. Asma Irfan

CONTACT

+923215016605; asma.irfan@imdcollege.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)