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NCT06984601

RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy

Sponsor: Turkish Society of Colon and Rectal Surgery

View on ClinicalTrials.gov

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.

Official title: RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy - Evaluating Function and Quality of Life: A National, Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-06-01

Completion Date

2027-05-31

Last Updated

2025-05-22

Healthy Volunteers

No

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.