RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy

NCT ID: NCT06984601

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-05-31

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.

Conditions

Chronic Anal Fissure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tailored LIS

Participants undergoing tailored lateral internal sphincterotomy, with sphincter division based on spasm severity or fissure characteristics

Lateral Internal Sphincterotomy (LIS)

Intervention Type: PROCEDURE

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

Classical LIS

Participants undergoing traditional sphincterotomy, with incision to the fissure apex or a fixed anatomical point

Lateral Internal Sphincterotomy (LIS)

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish Society of Colon and Rectal Surgery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sezai Leventoğlu, Proffesor

Role: STUDY_CHAIR

Gazi University

Central Contacts

Ender Ergüder, Dr.

Role: CONTACT

endererguder93@gmail.com

+905053912170

Other Identifiers

187

Identifier Type: -

Identifier Source: org_study_id