Clinical trial NCT06984601: RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy
Official title: RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy - Evaluating Function and Quality of Life: A National, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Anal Fissure
Keywords: Chronic anal fissure
Lateral internal sphincterotomy
Fecal incontinence
Lead sponsor: Turkish Society of Colon and Rectal Surgery
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients with a clinically significant change in fecal incontinence
timeFrame: Baseline, 12 months postoperatively
Secondary outcomes:
measure: Fecal Incontinence Quality of Life (FIQoL) Scale Score
timeFrame: Baseline, 3 - 12 months after surgery
measure: Short Form-36 (SF-36) Health Survey Score
timeFrame: Baseline, 3 - 12 months after surgery
measure: Change in disease-specific quality of life measured by the Hemo-Fiss-QoL questionnaire
timeFrame: Baseline, 3 - 12 months after surgery
measure: Change in Anxiety and Depression Scores (HADS)
timeFrame: 7-10 days, 3 months, 12 months
measure: Change in Pain Scores Using Visual Analog Scale (VAS)
timeFrame: 7-10 days, 3 months, 12 months
measure: Patient Satisfaction Score
timeFrame: 12 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Sezai Leventoğlu, Proffesor
role: STUDY_CHAIR
References: