An interventional study of Botulinum Toxin Type A (BOTOX) Injection and Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty in Anal Fissure Chronic, sponsored by Islamabad Medical and Dental College. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Islamabad Medical and Dental College · Not applicable, Interventional, and Treatment
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.
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.
84 studies on the registry are indexed under Fissure in Ano; 16 are open to participants now.
This study's planned enrollment of 108 is close to the median of 99 across 65 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →Islamabad Medical and Dental College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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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
Exclusion Criteria:
Acute anal fissure Inflammatory bowel disease Anal Previous anal surgery Pregnancy Pre-existing fecal incontinence patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 3 Months After Treatment for primary outcome in terms of chronic anal fissure healing
Plan to share: No
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Studies of the drug tested here: Botulinum toxin type A
Islamabad Medical and Dental College