RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTurkish Society of Colon and Rectal Surgery

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lateral Internal Sphincterotomy (LIS)

    Procedure/Surgery

    This is a routinely performed surgical procedure for chronic anal fissure. The study is observational and does not assign this procedure to participants.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Tailored LIS1 intervention
Group B: Classical LIS1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 12 months postoperatively

Secondary outcomes

1

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.

Time frame
Baseline, 3 - 12 months after surgery
2

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.

Time frame
Baseline, 3 - 12 months after surgery
3

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.

Time frame
Baseline, 3 - 12 months after surgery
4

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.

Time frame
7-10 days, 3 months, 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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