Chronic Anal FissureSTCAFNCT05117697
Surgical Treatment of a Chronic Anal Fissure
A study testing lateral subcutaneous sphincterotomy in people with Chronic Anal Fissure, run by State Scientific Centre of Coloproctology, Russian Federation at 2 sites in Russia.
Trial summary
This study is aimed at studying the effectiveness and safety of surgical treatment of 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?
- lateral subcutaneous sphincterotomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Nov 2021to 1 May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic anal fissure
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
- Pregnancy and lactation
- Anal sphincter insufficiency
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
SSCCRussia
Moscow, 123423
Sergey A Frolov, phd, +79039689739 ext. 89039689739, DrZharkow@mail.ru
Evgeny E Zharkov, 89039689739 ext. 89039689739, drzharkov@mail.ru
- Recruiting
Nikolay Goloktionov
Moscow
Nikolay 123423 Goloktionov, 1, +79154835433 ext. +79154835433, kolagolok1121995@mail.ru
About this study
Official title: Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.
This study is aimed at studying the effectiveness and safety of surgical treatment of 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 able-bodied 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.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.
- Conditions
- Chronic Anal Fissure
- Being tested
- lateral subcutaneous sphincterotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral subcutaneous sphincterotomyOther
Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy.
In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.
| Study group | Role | What they receive |
|---|---|---|
| main group | Experimental | Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. Receives: Other: lateral subcutaneous sphincterotomy |
| control group | Experimental | In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy. Receives: Other: lateral subcutaneous sphincterotomy |
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 incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).
Measured: Up to 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 7, 30 and 60
Non-Healing Wound
Frequency of post-operative wound epithelialization
Measured: On day 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 and 60
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 posted11 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 A comparative,randomized, prospective, single-center clinical study. Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117697
- Sponsor's protocol ID
- 56IG701SSCC977
- Acronym
- STCAF
- Status last verified
- Nov 2021
- First submitted
- 7 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.
- ClinicalTrials.gov ID
- NCT05117697
- Acronym / sponsor ID
- STCAF / 56IG701SSCC977
- Conditions
- Chronic Anal Fissure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 11 Nov 2021 (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 is aimed at studying the effectiveness and safety of surgical treatment of 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 able-bodied 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.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment A comparative,randomized, prospective, single-center clinical study. Patients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy.
| Arm | Type | Receives |
|---|---|---|
| main group | Experimental | Other: lateral subcutaneous sphincterotomyPatients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. |
| control group | Experimental | Other: lateral subcutaneous sphincterotomyIn the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy. |
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
Key exclusion criteria (8 listed)
- Inflammatory diseases of the colon
- Pectenosis
- Previous surgical interventions on the anal canal
- IV grade internal and external hemorrhoids
- Rectal fistula
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 |
|---|---|---|
| lateral subcutaneous sphincterotomyPatients of the main group are treated with a crack by performing a lateral subcutaneous sphincterotomy. In the control group, the fissure is excised in combination with a lateral subcutaneous sphincterotomy. | Other | control group, main group |
Primary outcome
Anal sphincter insufficiency
Time frame: Up to 60 days
Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).
5 secondary outcomes
2-item pain intensity (P2)
Time frame: On day 7, 30 and 60
Non-Healing Wound
Time frame: On day 60
Profilometry /sphincterometry findings
Time frame: On day 30 and 60
Temporary disability
Time frame: Up to 60 days
Relap
Time frame: Up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral subcutaneous sphincterotomy in people with Chronic Anal Fissure, run by State Scientific Centre of Coloproctology, Russian Federation at 2 sites 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 8 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anal sphincter insufficiency (time frame: Up to 60 days). 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 11 Nov 2021.