RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy

NCT06984601 | Not Yet Recruiting DMC

• 1 other identifier: 187
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Anal Fissure

Keywords

Chronic anal fissure; Lateral internal sphincterotomy; Fecal incontinence

Outcome Measures

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.

  Baseline, 12 months postoperatively

Secondary Outcomes (6)

• Fecal Incontinence Quality of Life (FIQoL) Scale Score

  Baseline, 3 - 12 months after surgery

• Short Form-36 (SF-36) Health Survey Score

  Baseline, 3 - 12 months after surgery

• Change in disease-specific quality of life measured by the Hemo-Fiss-QoL questionnaire

  Baseline, 3 - 12 months after surgery

• Change in Anxiety and Depression Scores (HADS)

  7-10 days, 3 months, 12 months

• Change in Pain Scores Using Visual Analog Scale (VAS)

  7-10 days, 3 months, 12 months

Study Arms (2)

Tailored LIS

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

Procedure: Lateral Internal Sphincterotomy (LIS)

Classical LIS

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

Procedure: Lateral Internal Sphincterotomy (LIS)

Interventions

Lateral Internal Sphincterotomy (LIS) 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; Tailored LIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turkish Society of Colon and Rectal Surgery: lead

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Lateral Internal Sphincterotomy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Officials

• Sezai Leventoğlu, Proffesor

  Gazi University

  STUDY CHAIR

Central Study Contacts

Ender Ergüder, Dr.

CONTACT

+905053912170; endererguder93@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF