Anal Fissure ChronicNCT07665528
Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure
A study testing Botulinum Toxin Type A (BOTOX) Injection and Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty in people with Anal Fissure Chronic, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fissure Chronic
- What is being tested?
- Botulinum Toxin Type A (BOTOX) Injection and Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2026to 3 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute anal fissure Inflammatory bowel disease Anal malignancy Previous anal surgery Pregnancy Pre-existing fecal incontinence Immunocompromised patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Islamabad Medical and Dental College
Islamabad, Federal, 44000
Prof. Dr. Asma Irfan, +923215016605, asma.irfan@imdcollege.edu.pk
Dr. Imtiaz Ahmed Khattak, +923339223185, drimtiazkhattak@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Anal Fissure Chronic
- Being tested
- Botulinum Toxin Type A (BOTOX) Injection, Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A (BOTOX) InjectionDrug
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.
Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and AnoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months After Treatment for primary outcome in terms of chronic anal fissure healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start3 Jun 2026
- Primary completion3 Sep 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Fissure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665528
- Sponsor's protocol ID
- IMDC-CRS-CAF-2026-01
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Injection Botox Alone Versus Injection Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure
- ClinicalTrials.gov ID
- NCT07665528
- Acronym / sponsor ID
- IMDC-CRS-CAF-2026-01
- Conditions
- Anal Fissure Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection Botox Alone | Experimental | Drug: Botulinum Toxin Type A (BOTOX) InjectionParticipants 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. |
| Injection Botox Plus Fissurectomy and Anoplasty | Active comparator | Procedure: Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and AnoplastyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Acute anal fissure Inflammatory bowel disease Anal malignancy Previous anal surgery Pregnancy Pre-existing fecal incontinence Immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A (BOTOX) InjectionBotulinum 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. | Drug | Injection Botox Alone |
| Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and AnoplastyFollowing 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. | Procedure or surgery | Injection Botox Plus Fissurectomy and Anoplasty |
Primary outcome
Fissure Healing Rate
Time frame: 3 Months After Treatment for primary outcome in terms of chronic anal fissure healing
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A (BOTOX) Injection and Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty in people with Anal Fissure Chronic, run by Islamabad Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Rizwan Aziz (+923008444229, aziz.rizwan@imdcollege.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fissure Healing Rate (time frame: 3 Months After Treatment for primary outcome in terms of chronic anal fissure healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.