About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Lateral Internal Sphincterotomy (LIS)
Procedure/SurgeryThis is a routinely performed surgical procedure for chronic anal fissure. The study is observational and does not assign this procedure to participants.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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