Chronic Anal FissureRELIEFNCT06984601
RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy
An observational study of Chronic Anal Fissure, run by Turkish Society of Colon and Rectal Surgery.
Trial summary
The goal of this observational study is to learn how a common surgery called lateral internal sphincterotomy (LIS) affects people with chronic anal fissures, a painful tear near the anus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- Lateral Internal Sphincterotomy (LIS)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 May 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older diagnosed with chronic anal fissure who are undergoing lateral internal sphincterotomy (LIS) as part of routine clinical care. Participants will be recruited from multiple surgical centers across Turkey. The study includes both male and female patients with no upper age limit.
Who may be able to join
- Adults aged 18 years or older
- Diagnosed with chronic anal fissure (symptoms lasting more than 6 weeks)
- Decision for lateral internal sphincterotomy (LIS) made by the treating physician
- Able to understand and complete study-related questionnaires
Who cannot join
- Presence of other anorectal or rectal diseases (e.g., fistula, abscess, inflammatory bowel disease)
- History of prior anal surgery or pelvic radiation
- Inability to comprehend study-related forms or provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy - Evaluating Function and Quality of Life: A National, Prospective Cohort Study
The goal of this observational study is to learn how a common surgery called lateral internal sphincterotomy (LIS) affects people with chronic anal fissures, a painful tear near the anus. The study will look at whether this surgery helps lower problems like pain and incontinence, and how it affects quality of life and mental health.
The main questions the study aims to answer are:
Read more
Does LIS surgery lower the rate of incontinence one year after surgery? Does it improve quality of life, reduce pain, and increase patient satisfaction?
Participants will:
Have surgery for chronic anal fissure called LIS. Complete short surveys about pain and mental health at 1 week, 3 months, and 12 months.
Answer questions about bowel function, incontinence and daily life at 3 and 12 months.
Researchers will follow about 300 adults at hospitals across the Turkey. This study will help improve future treatment decisions and make surgery safer and more effective.
Read the detailed description
Chronic anal fissure is a common anorectal condition that can significantly affect daily life due to pain and difficulty with bowel movements. Lateral internal sphincterotomy (LIS) is a widely used surgical treatment for fissures that do not improve with medical therapy. While LIS is highly effective in promoting healing, it may lead to complications such as fecal incontinence, which can negatively affect quality of life.
The RELIEF Study is a prospective, multicenter cohort study conducted across several hospitals in Turkey. The aim is to evaluate the long-term effects of LIS on bowel control, postoperative pain, patient satisfaction, and mental health. Participants will be followed for 12 months after surgery. Data will be collected using a secure electronic data capture system (REDCap) to ensure standardization and data quality.
Approximately 300 adult participants will be enrolled. Researchers will examine different surgical approaches to LIS, including tailored techniques (based on fissure location or sphincter tone) and classical methods (such as sphincterotomy to the fissure apex). By comparing outcomes across these techniques, the study will help identify safer and more effective strategies.
Validated tools, including incontinence scores, pain scales, and quality of life questionnaires, will be used to measure outcomes. The findings are expected to inform clinical practice and contribute to the development of evidence-based guidelines for the treatment of chronic anal fissures.
- Conditions
- Chronic Anal Fissure
- Being tested
- Lateral Internal Sphincterotomy (LIS)
- Keywords
- Chronic anal fissure, Lateral internal sphincterotomy, Fecal incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Internal Sphincterotomy (LIS)Procedure or surgery
This is a routinely performed surgical procedure for chronic anal fissure. The study is observational and does not assign this procedure to participants.
| Study group | Role | What they receive |
|---|---|---|
| Tailored LIS | Participants undergoing tailored lateral internal sphincterotomy, with sphincter division based on spasm severity or fissure characteristics Receives: Procedure: Lateral Internal Sphincterotomy (LIS) | |
| Classical LIS | Participants undergoing traditional sphincterotomy, with incision to the fissure apex or a fixed anatomical point Receives: Procedure: Lateral Internal Sphincterotomy (LIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a clinically significant change in fecal incontinence
A clinically significant improvement is defined as a reduction of ≥2 points in the Cleveland Clinic Incontinence Score (Wexner Score), which ranges from 0 (perfect continence) to 20 (complete incontinence). Higher scores indicate worse fecal incontinence. The proportion of patients achieving this threshold will be calculated at 12 months postoperatively.
Measured: Baseline, 12 months postoperatively
Secondary outcomes (6)
Fecal Incontinence Quality of Life (FIQoL) Scale Score
The Fecal Incontinence Quality of Life (FIQoL) scale is a 29-item patient-reported questionnaire that assesses quality of life in patients with fecal incontinence. It consists of four subscales (Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment). Each item is scored from 1 to 4, with subscale scores calculated as the average of the corresponding item scores. Possible scores range from 1 (minimum) to 4 (maximum), with higher scores indicating better quality of life.
Measured: Baseline, 3 - 12 months after surgery
Short Form-36 (SF-36) Health Survey Score
The Short Form-36 (SF-36) Health Survey is a validated 36-item questionnaire assessing health-related quality of life across 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status. Composite summary scores (Physical and Mental Component Summary) may also be calculated.
Measured: Baseline, 3 - 12 months after surgery
Change in disease-specific quality of life measured by the Hemo-Fiss-QoL questionnaire
The Hemo-Fiss-QoL is a validated disease-specific tool for assessing quality of life in patients with hemorrhoids or anal fissure. Total scores range from 0 to 100, with higher scores indicating worse quality of life.
Measured: Baseline, 3 - 12 months after surgery
Change in Anxiety and Depression Scores (HADS)
Anxiety will be assessed using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). This subscale includes 7 items, each scored from 0 to 3, yielding a total score from 0 (no anxiety) to 21 (severe anxiety). Higher scores indicate worse anxiety symptoms.
Measured: 7-10 days, 3 months, 12 months
Change in Pain Scores Using Visual Analog Scale (VAS)
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will self-report their pain intensity. Higher scores indicate worse pain.
Measured: 7-10 days, 3 months, 12 months
Patient Satisfaction Score
Patient satisfaction with the surgical outcome will be assessed using a self-reported 5-point Likert scale, where:
1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Very Satisfied Higher scores indicate greater satisfaction with treatment.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Colon and Rectal Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sezai Leventoğlu, Proffesor, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984601
- Sponsor's protocol ID
- 187
- Acronym
- RELIEF
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request. Data will be anonymized and made available to qualified researchers after approval by the study committee.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy - Evaluating Function and Quality of Life: A National, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06984601
- Acronym / sponsor ID
- RELIEF / 187
- Conditions
- Chronic Anal Fissure
- Keywords
- Chronic anal fissure, Lateral internal sphincterotomy, Fecal incontinence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Turkish Society of Colon and Rectal SurgeryUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 May 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 goal of this observational study is to learn how a common surgery called lateral internal sphincterotomy (LIS) affects people with chronic anal fissures, a painful tear near the anus. The study will look at whether this surgery helps lower problems like pain and incontinence, and how it affects quality of life and mental health.
The main questions the study aims to answer are:
Does LIS surgery lower the rate of incontinence one year after surgery? Does it improve quality of life, reduce pain, and increase patient satisfaction?
Participants will:
Have surgery for chronic anal fissure called LIS. Complete short surveys about pain and mental health at 1 week, 3 months, and 12 months.
Answer questions about bowel function, incontinence and daily life at 3 and 12 months.
Researchers will follow about 300 adults at hospitals across the Turkey. This study will help improve future treatment decisions and make surgery safer and more effective.
Detailed description
Chronic anal fissure is a common anorectal condition that can significantly affect daily life due to pain and difficulty with bowel movements. Lateral internal sphincterotomy (LIS) is a widely used surgical treatment for fissures that do not improve with medical therapy. While LIS is highly effective in promoting healing, it may lead to complications such as fecal incontinence, which can negatively affect quality of life.
The RELIEF Study is a prospective, multicenter cohort study conducted across several hospitals in Turkey. The aim is to evaluate the long-term effects of LIS on bowel control, postoperative pain, patient satisfaction, and mental health. Participants will be followed for 12 months after surgery. Data will be collected using a secure electronic data capture system (REDCap) to ensure standardization and data quality.
Approximately 300 adult participants will be enrolled. Researchers will examine different surgical approaches to LIS, including tailored techniques (based on fissure location or sphincter tone) and classical methods (such as sphincterotomy to the fissure apex). By comparing outcomes across these techniques, the study will help identify safer and more effective strategies.
Validated tools, including incontinence scores, pain scales, and quality of life questionnaires, will be used to measure outcomes. The findings are expected to inform clinical practice and contribute to the development of evidence-based guidelines for the treatment of chronic anal fissures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored LIS | – | Procedure: Lateral Internal Sphincterotomy (LIS)Participants undergoing tailored lateral internal sphincterotomy, with sphincter division based on spasm severity or fissure characteristics |
| Classical LIS | – | Procedure: Lateral Internal Sphincterotomy (LIS)Participants undergoing traditional sphincterotomy, with incision to the fissure apex or a fixed anatomical point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older diagnosed with chronic anal fissure who are undergoing lateral internal sphincterotomy (LIS) as part of routine clinical care. Participants will be recruited from multiple surgical centers across Turkey. The study includes both male and female patients with no upper age limit.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Diagnosed with chronic anal fissure (symptoms lasting more than 6 weeks)
- Decision for lateral internal sphincterotomy (LIS) made by the treating physician
- Able to understand and complete study-related questionnaires
Key exclusion criteria (3 listed)
- Presence of other anorectal or rectal diseases (e.g., fistula, abscess, inflammatory bowel disease)
- History of prior anal surgery or pelvic radiation
- Inability to comprehend study-related forms or provide informed consent
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 Internal Sphincterotomy (LIS)This is a routinely performed surgical procedure for chronic anal fissure. The study is observational and does not assign this procedure to participants. | Procedure or surgery | Classical LIS, Tailored LIS |
Primary outcome
Proportion of patients with a clinically significant change in fecal incontinence
Time frame: Baseline, 12 months postoperatively
A clinically significant improvement is defined as a reduction of ≥2 points in the Cleveland Clinic Incontinence Score (Wexner Score), which ranges from 0 (perfect continence) to 20 (complete incontinence). Higher scores indicate worse fecal incontinence. The proportion of patients achieving this threshold will be calculated at 12 months postoperatively.
6 secondary outcomes
Fecal Incontinence Quality of Life (FIQoL) Scale Score
Time frame: Baseline, 3 - 12 months after surgery
Short Form-36 (SF-36) Health Survey Score
Time frame: Baseline, 3 - 12 months after surgery
Change in disease-specific quality of life measured by the Hemo-Fiss-QoL questionnaire
Time frame: Baseline, 3 - 12 months after surgery
Change in Anxiety and Depression Scores (HADS)
Time frame: 7-10 days, 3 months, 12 months
Change in Pain Scores Using Visual Analog Scale (VAS)
Time frame: 7-10 days, 3 months, 12 months
Patient Satisfaction Score
Time frame: 12 months after surgery
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 22 May 2025.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request. Data will be anonymized and made available to qualified researchers after approval by the study committee.
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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.
Sezai Leventoğlu, Proffesor study chair
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Anal Fissure, run by Turkish Society of Colon and Rectal Surgery.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ender Ergüder, Dr. (+905053912170, endererguder93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a clinically significant change in fecal incontinence (time frame: Baseline, 12 months postoperatively). 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 22 May 2025.