RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy
NCT06984601 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2025-05-22
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.
Conditions
- Chronic Anal Fissure
Interventions
- PROCEDURE
-
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.
Sponsors & Collaborators
-
Turkish Society of Colon and Rectal Surgery
lead OTHER
Principal Investigators
-
Sezai Leventoğlu, Proffesor · Gazi University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2026-05-31
- Completion
- 2027-05-31
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