Clinical Research Directory

Low Versus High Dose OnabotulinumtoxinA for Chronic Anal Fissure

This prospective single-center cohort study describes short-term and one-year clinical outcomes of two routine doses of OnabotulinumtoxinA (20 units versus 50 units) for chronic anal fissure refractory to conservative therapy. The dose was determined by each surgical unit's established routine practice and was not assigned by the investigators. Both doses were given as bilateral internal sphincter injections at the 3 and 9 o'clock positions in an equal 1-mL volume. The primary outcome is disease-specific quality of life (HEMO-FISS-QoL) at 1 month. Patients are followed for 12 months for pain, healing, continence, recurrence and need for lateral internal sphincterotomy.

Topical Nitroglycerin Versus Lateral Internal Sphincterotomy for Chronic Anal Fissure

Chronic anal fissure is a tear in the lining of the anal canal that can cause pain during and after defecation. This randomized controlled trial will compare topical 0.2% nitroglycerin ointment with lateral internal sphincterotomy in adults with chronic anal fissure. A total of 72 eligible participants will be allocated to one of two treatment groups. The nitroglycerin group will receive topical treatment twice daily for six weeks, while the surgical group will undergo lateral internal sphincterotomy. Participants will be assessed at Day 7 and Weeks 2, 3, 4 and 8. The study will compare the time required for pain relief and complete fissure healing between the two treatment groups.

AI-Assisted Written Information in Chronic Anal Fissure

This single-center, prospective, 1:1 randomized, parallel-group controlled superiority trial compares standard verbal counseling with AI-assisted written patient information in adults with primary chronic anal fissure receiving initial medical/conservative treatment. The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14. Secondary objectives include pain and discomfort outcomes, Patient Global Impression of Change, HEMO-FISS-QoL change, stool form change, additional healthcare visits, transition to interventional treatment, and patient satisfaction.

Emerging Indications for Hyperbaric Oxygen Treatment

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Female Sexual Function After Surgery for Benign Perianal Diseases

Benign perianal diseases such as chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula may negatively affect female sexual function through pain, bleeding, discharge, discomfort, and impairment in quality of life. Although improvement in male sexual function after surgery for benign anorectal disorders has been reported, data regarding female sexual function remain limited. This prospective observational cohort study aims to evaluate changes in Female Sexual Function Index (FSFI) scores following surgical treatment of benign perianal diseases. Female patients undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be assessed preoperatively and at postoperative 3 and 6 months using the FSFI, Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS). The primary objective is to determine whether female sexual function improves following surgical treatment. Secondary objectives include evaluating the relationship between symptom improvement, continence status, pain reduction, and changes in female sexual function.

Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure

This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.

E-CEL UVEC Treatment for Anal Fissures

This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure. The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure.

Combined Method of Surgical Treatment of Anal Fissure

The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.

RELIEF Study: Resolving Fissures With Lateral Internal Sphincterotomy

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.