Anal Fissure ChronicBOT-LIS-CAFNCT07568314
Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management
A study testing Botulinum Toxin Type A (BOTOX) Injection and Lateral Internal Sphincterotomy in people with Anal Fissure Chronic, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial summary
This study aims to compare two commonly used treatments for chronic anal fissure: botulinum toxin injection and lateral internal sphincterotomy. Chronic anal fissure is a painful condition that causes severe discomfort during bowel movements and can significantly affect a patient's quality of life. 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 Lateral Internal Sphincterotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Mar 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18-65 years
- Diagnosed chronic anal fissure (>6 weeks duration)
- Failure of conservative management
- Both male and female patients
- Willingness to provide informed consent
Who cannot join
- Acute anal fissure
- Previous anal surgery
- Inflammatory bowel disease
- Pregnancy
- Neurological disorders affecting continence
- Known hypersensitivity to botulinum toxin
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islamabad Medical and Dental College
Islamabad, Federal, 44000
About this study
Official title: A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure
This study aims to compare two commonly used treatments for chronic anal fissure: botulinum toxin injection and lateral internal sphincterotomy. Chronic anal fissure is a painful condition that causes severe discomfort during bowel movements and can significantly affect a patient's quality of life.
Botulinum toxin injection is a minimally invasive procedure that temporarily relaxes the anal sphincter muscle to promote healing. In contrast, lateral internal sphincterotomy is a minor surgical procedure that permanently reduces sphincter pressure and is considered the standard treatment with high healing rates.
Read more
A total of 90 adult patients with chronic anal fissure will be enrolled and divided into two groups. One group will receive botulinum toxin injection, while the other group will undergo lateral internal sphincterotomy. Patients will be followed up regularly to assess healing, pain relief, recurrence of the fissure, and any complications such as incontinence.
The purpose of this study is to determine which treatment provides better outcomes in terms of effectiveness and safety, helping doctors choose the most appropriate treatment for patients.
- Conditions
- Anal Fissure Chronic
- Being tested
- Botulinum Toxin Type A (BOTOX) Injection, Lateral Internal Sphincterotomy
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
A total dose of 20 units of botulinum toxin type A will be administered via intrasphincteric injection. The toxin will be diluted in 1 ml of normal saline and injected into the internal anal sphincter in two equal doses of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane using a 26-30 gauge needle under aseptic conditions.
Lateral Internal SphincterotomyProcedure or surgery
An open lateral internal sphincterotomy will be performed under spinal anesthesia. A small lateral incision will be made at the 3 o'clock position, and the lower one-third of the internal anal sphincter will be divided under direct vision. Hemostasis will be achieved, and the wound will be left open to heal by secondary intention.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Injection | Experimental | Participants in this arm will receive an intrasphincteric injection of 20 units of botulinum toxin type A. The toxin will be diluted in 1 ml of normal saline and administered as two injections of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane under aseptic conditions using a 26-30 gauge needle. Receives: Drug: Botulinum Toxin Type A (BOTOX) Injection |
| Lateral Internal Sphincterotomy | Active comparator | Participants in this arm will undergo open lateral internal sphincterotomy under spinal anesthesia. A small incision will be made at the lateral position (3 o'clock), and the lower one-third of the internal anal sphincter will be divided under direct vision. Hemostasis will be secured, and the wound will be left open for secondary healing Receives: Procedure: Lateral Internal Sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete fissure healing at 3 months after treatment (Botulinum toxin vs. Lateral Internal Sphincterotomy). This is the main endpoint on which your sample size calculation and comparative effectiveness analysis are based.
Measured: 3 months for healing after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start2 Mar 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
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
- 90 participants (actual)
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
- NCT07568314
- Sponsor's protocol ID
- ANTH-GS-CAF-2026
- Acronym
- BOT-LIS-CAF
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure
- ClinicalTrials.gov ID
- NCT07568314
- Acronym / sponsor ID
- BOT-LIS-CAF / ANTH-GS-CAF-2026
- Conditions
- Anal Fissure Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 5 May 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.
This study aims to compare two commonly used treatments for chronic anal fissure: botulinum toxin injection and lateral internal sphincterotomy. Chronic anal fissure is a painful condition that causes severe discomfort during bowel movements and can significantly affect a patient's quality of life.
Botulinum toxin injection is a minimally invasive procedure that temporarily relaxes the anal sphincter muscle to promote healing. In contrast, lateral internal sphincterotomy is a minor surgical procedure that permanently reduces sphincter pressure and is considered the standard treatment with high healing rates.
A total of 90 adult patients with chronic anal fissure will be enrolled and divided into two groups. One group will receive botulinum toxin injection, while the other group will undergo lateral internal sphincterotomy. Patients will be followed up regularly to assess healing, pain relief, recurrence of the fissure, and any complications such as incontinence.
The purpose of this study is to determine which treatment provides better outcomes in terms of effectiveness and safety, helping doctors choose the most appropriate treatment for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Injection | Experimental | Drug: Botulinum Toxin Type A (BOTOX) InjectionParticipants in this arm will receive an intrasphincteric injection of 20 units of botulinum toxin type A. The toxin will be diluted in 1 ml of normal saline and administered as two injections of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane under aseptic conditions using a 26-30 gauge needle. |
| Lateral Internal Sphincterotomy | Active comparator | Procedure: Lateral Internal SphincterotomyParticipants in this arm will undergo open lateral internal sphincterotomy under spinal anesthesia. A small incision will be made at the lateral position (3 o'clock), and the lower one-third of the internal anal sphincter will be divided under direct vision. Hemostasis will be secured, and the wound will be left open for secondary healing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- Diagnosed chronic anal fissure (>6 weeks duration)
- Failure of conservative management
- Both male and female patients
- Willingness to provide informed consent
Key exclusion criteria (6 listed)
- Acute anal fissure
- Previous anal surgery
- Inflammatory bowel disease
- Pregnancy
- Neurological disorders affecting continence
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) InjectionA total dose of 20 units of botulinum toxin type A will be administered via intrasphincteric injection. The toxin will be diluted in 1 ml of normal saline and injected into the internal anal sphincter in two equal doses of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane using a 26-30 gauge needle under aseptic conditions. | Drug | Botulinum Toxin Injection |
| Lateral Internal SphincterotomyAn open lateral internal sphincterotomy will be performed under spinal anesthesia. A small lateral incision will be made at the 3 o'clock position, and the lower one-third of the internal anal sphincter will be divided under direct vision. Hemostasis will be achieved, and the wound will be left open to heal by secondary intention. | Procedure or surgery | Lateral Internal Sphincterotomy |
Primary outcome
Proportion of patients with complete fissure healing at 3 months after treatment (Botulinum toxin vs. Lateral Internal Sphincterotomy). This is the main endpoint on which your sample size calculation and comparative effectiveness analysis are based.
Time frame: 3 months for healing after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for Anal Fissure Chronic
RecruitingObservational study
Ultrasound Assessment After Surgery for Chronic Anal Fissure
Anal Fissure Chronic
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
AI-Assisted Written Information in Chronic Anal Fissure
Chronic Anal Fissure
Recruiting
Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure
Anal Fissure Chronic
Not yet recruitingObservational study
Female Sexual Function After Surgery for Benign Perianal Diseases
Chronic Anal Fissure, Hemorrhoidal Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Lateral Internal Sphincterotomy 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 13 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete fissure healing at 3 months after treatment (Botulinum toxin vs. Lateral Internal Sphincterotomy). This is the main endpoint on which your sample size calculation and comparative effectiveness analysis are based. (time frame: 3 months for healing after intervention). 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 13 Aug 2026.