Chronic Anal FissureNCT07268261
Combined Method of Surgical Treatment of Anal Fissure
A study testing excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A in people with Chronic Anal Fissure, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2023to 1 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with chronic anal fissure with spasm of anal sphincter
Who cannot join
- • Inflammatory diseases of the colon
- Pectenosis
- Previous surgical interventions on the anal canal
- IV grade internal and external hemorrhoids
- Rectal fistula
- Severe somatic diseases at the decompensation stage
Show all 13Show fewer
- Pregnancy and lactation
- Anal sphincter insufficiency
- Chronic paraproctitis
- Individual intolerance and hypersensitivity to botulinum toxin
- Myasthenia gravis and myasthenic syndromes
- History of allergic reaction to anticoagulants.
- Blood diseases (thrombocytopenia, splenomegaly, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
SSCCRussia
Moscow, 123423
Sergey A Frolov, phd, +79039689739 ext. 89039689739, DrZharkow@mail.ru
Evgeny E Zharkov, +79039689739 ext. +79039689739, drzharkov@mail.ru
About this study
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Read the detailed description
A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance.
The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early postoperative period.
Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence)
- Conditions
- Chronic Anal Fissure
- Being tested
- excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A
- Keywords
- Fissure in Ano, Anal fissure, botulinum toxin A, Chronic anal pain, Fecal incontinence, Spasm of the internal sphincter, Anal sphincter insufficiency
- Medical subject headings
- Fissure in Ano, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin AProcedure or surgery
patients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added
| Study group | Role | What they receive |
|---|---|---|
| main group | Experimental | Patients of the main group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each) Receives: Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A |
| control group | Experimental | Patients in the control group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each) Receives: Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal sphincter insufficiency
Frequency of anal sphincter insufficiency according to the Wexner scale
Measured: 60 days
Secondary outcomes (5)
2-item pain intensity (P2)
Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).
Measured: On day 15, 30, 45 and 60
Non-Healing Wound
Frequency of post-operative wound epithelialization
Measured: On day 15, 30, 45, 60
Profilometry /sphincterometry findings
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Measured: On day 30, 60 and 365
Temporary disability
Duration of temporary disability
Measured: Up to 60 days
Relap
Frequency of relapses
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Sep 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Anal FissureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment. Comparative, randomized, prospective, single-center. clinical trial. Patients in the main group undergo excision of the fissure in combination with injection into internal sphincter Botulinum toxin type A In the control group, excision of the fissure was performed in combination with injection into internal sphincter Botulinum toxin type A with excision in combination with platelet rich plasma
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey A. Frolov, Ph.D, Principal investigator, State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268261
- Sponsor's protocol ID
- 56IG701SSCC980
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016.
PubMed 8351556Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
PubMed 8416784Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
PubMed 22336789Zetterstrom J, Mellgren A, Jensen LL, Wong WD, Kim DG, Lowry AC, Madoff RD, Congilosi SM. Effect of delivery on anal sphincter morphology and function. Dis Colon Rectum. 1999 Oct;42(10):1253-60. doi: 10.1007/BF02234209.
PubMed 10528760Delechenaut P, Leroi AM, Weber J, Touchais JY, Czernichow P, Denis P. Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry. Dis Colon Rectum. 1992 Sep;35(9):847-9. doi: 10.1007/BF02047871.
PubMed 1511644Chen HL, Woo XB, Wang HS, Lin YJ, Luo HX, Chen YH, Chen CQ, Peng JS. Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials. Tech Coloproctol. 2014 Aug;18(8):693-8. doi: 10.1007/s10151-014-1121-4. Epub 2014 Feb 6.
PubMed 24500725Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20.
PubMed 22430300Bobkiewicz A, Francuzik W, Krokowicz L, Studniarek A, Ledwosinski W, Paszkowski J, Drews M, Banasiewicz T. Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis. World J Surg. 2016 Dec;40(12):3064-3072. doi: 10.1007/s00268-016-3693-9.
PubMed 27539490Gui D, Cassetta E, Anastasio G, Bentivoglio AR, Maria G, Albanese A. Botulinum toxin for chronic anal fissure. Lancet. 1994 Oct 22;344(8930):1127-8. doi: 10.1016/s0140-6736(94)90633-5.
PubMed 7934496Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.
PubMed 27926552
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Method of Surgical Treatment of Anal Fissure
- ClinicalTrials.gov ID
- NCT07268261
- Acronym / sponsor ID
- 56IG701SSCC980
- Conditions
- Chronic Anal Fissure
- Keywords
- Fissure in Ano, Anal fissure, botulinum toxin A, Chronic anal pain, Fecal incontinence, Spasm of the internal sphincter, Anal sphincter insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Detailed description
A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance.
The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early postoperative period.
Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment. Comparative, randomized, prospective, single-center. clinical trial. Patients in the main group undergo excision of the fissure in combination with injection into internal sphincter Botulinum toxin type A In the control group, excision of the fissure was performed in combination with injection into internal sphincter Botulinum toxin type A with excision in combination with platelet rich plasma
| Arm | Type | Receives |
|---|---|---|
| main group | Experimental | Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin APatients of the main group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each) |
| control group | Experimental | Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin APatients in the control group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients with chronic anal fissure with spasm of anal sphincter
Key exclusion criteria (13 listed)
- • Inflammatory diseases of the colon
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 |
|---|---|---|
| excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin Apatients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added | Procedure or surgery | control group, main group |
Primary outcome
Anal sphincter insufficiency
Time frame: 60 days
Frequency of anal sphincter insufficiency according to the Wexner scale
5 secondary outcomes
2-item pain intensity (P2)
Time frame: On day 15, 30, 45 and 60
Non-Healing Wound
Time frame: On day 15, 30, 45, 60
Profilometry /sphincterometry findings
Time frame: On day 30, 60 and 365
Temporary disability
Time frame: Up to 60 days
Relap
Time frame: Up to 60 days
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 5 Dec 2025.
- Background: PubMed 8351556Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016.
- Background: PubMed 8416784Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
- Background: PubMed 22336789Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
- Background: PubMed 10528760Zetterstrom J, Mellgren A, Jensen LL, Wong WD, Kim DG, Lowry AC, Madoff RD, Congilosi SM. Effect of delivery on anal sphincter morphology and function. Dis Colon Rectum. 1999 Oct;42(10):1253-60. doi: 10.1007/BF02234209.
- Background: PubMed 1511644Delechenaut P, Leroi AM, Weber J, Touchais JY, Czernichow P, Denis P. Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry. Dis Colon Rectum. 1992 Sep;35(9):847-9. doi: 10.1007/BF02047871.
- Background: PubMed 24500725Chen HL, Woo XB, Wang HS, Lin YJ, Luo HX, Chen YH, Chen CQ, Peng JS. Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials. Tech Coloproctol. 2014 Aug;18(8):693-8. doi: 10.1007/s10151-014-1121-4. Epub 2014 Feb 6.
- Background: PubMed 22430300Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20.
- Background: PubMed 27539490Bobkiewicz A, Francuzik W, Krokowicz L, Studniarek A, Ledwosinski W, Paszkowski J, Drews M, Banasiewicz T. Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis. World J Surg. 2016 Dec;40(12):3064-3072. doi: 10.1007/s00268-016-3693-9.
- Background: PubMed 7934496Gui D, Cassetta E, Anastasio G, Bentivoglio AR, Maria G, Albanese A. Botulinum toxin for chronic anal fissure. Lancet. 1994 Oct 22;344(8930):1127-8. doi: 10.1016/s0140-6736(94)90633-5.
- Background: PubMed 27926552Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.
- 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.
Sergey A. Frolov, Ph.D principal investigator
State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A in people with Chronic Anal Fissure, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 13 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 5 Dec 2025. 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 Russia. 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 Evgeny E. Zharkov, MD (+79039689739, drzharkov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anal sphincter insufficiency (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07268261, which also lists 10 linked publications.
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 5 Dec 2025.